HTM CFPP 01 01a Final

Choice Framework for local Policy and
Procedures 01-01 Management and

decontamination of surgical
instruments (medical devices) used in
acute care. Part A: The formulation of
local policy and choices
Choice Framework for local Policy and
Procedures (CFPP) 01-01
Management and decontamination of
surgical instruments (medical devices) used in
acute care
Part A: The formulation of local policy and
choices
CFPP 01-01 Management and decontamination of surgical instruments: Part A The formulation of local policies and choices
ii
Crown copyright 2013
Terms of use for this guidance can be found at http://www.nationalarchives.gov.uk/doc/open-government-licence/

iii
Preface
Introduction
The Choice Framework for local Policy and Procedures
(CFPP) is an initiative being piloted by the Department
of Health.
It forms a suite of evidence-based policy and guidance
documents on the management and decontamination of
reusable medical devices.
Purpose
The purpose of CFPP is to enable local choices to be
made regarding the management, use and
decontamination of reusable medical devices at controlled
costs using risk control.
CFPP is designed to reflect the need to continuously
improve outcomes in terms of:
patient safety;
clinical effectiveness; and
patient experience.
Essential Quality Requirements and
Best Practice
The Health Act Code of Practice recommends that
healthcare organisations comply with guidance
establishing Essential Quality Requirements and
demonstrate that a plan is in place for progression to Best
Practice.
Essential Quality Requirements (EQR), for the purposes
of this best practice guidance, is a term that encompasses
all existing statutory and regulatory requirements. EQRs
incorporate requirements of the current Medical Devices
Directive and Approved Codes of Practice as well as
relevant applicable Standards. They will help to
demonstrate that an acute provider operates safely with
respect to its decontamination services.
Local policy should define how a provider achieves risk
control and what plan is in place to work towards Best
Practice.
Best Practice is additional to EQR. Best Practice as
defined in this guidance covers non-mandatory policies
and procedures that aim to further minimise risks to
patients; deliver better patient outcomes; promote and
encourage innovation and choice; and achieve cost
efficiencies.
Best Practice should be considered when developing local
policies and procedures based on the risk of surgical
procedures and available evidence. Best Practice
encompasses guidance on the whole of the
decontamination cycle, including, for example, improved
instrument management, where there is evidence that
these procedures will contribute to improved clinical
outcomes.
The CFPP suite is listed below.
Choice Framework for local Policy and Procedures
01-01: Management and decontamination of surgical
instruments (medical devices) used in acute care
01-04: Decontamination of linen for health and social
care
01-06: Decontamination of flexible endoscopes
iv
Andrew Thomas Royal College of Surgeons
Bill Keevil Southampton University
Brian Kirk IHEEM Decontamination Technology Platform
David Perrett Barts & the London School of Medicine & Dentistry, Queen Mary University of London
Gavin Maxwell Royal Society of Medicine Patients Support Group
Geoff Sjogren Institute of Decontamination Sciences
Geoffrey L. Ridgway, OBE, MD Clinical Microbiologist
Graham Stanton NHS Wales Shared Services Partnership Facilities Services
Helen Baxter University of Edinburgh
Jackie Duggan Health Protection Agency
James Ironside University of Edinburgh
Jim Gray Birmingham Childrens Hospital NHS Foundation Trust
Jimmy Walker Health Protection Agency
Ken Toal Health Estates, Northern Ireland
Margaret Hollis Great Ormond Street Hospital
Mike Painter Public Health Physician
Mike Simmons Public Health Wales
Peter Brigham Newcastle upon Tyne Hospitals NHS Foundation Trust
Peter Hoffman Health Protection Agency
Robert Baxter University of Edinburgh
Robert Kingston IHEEM Decontamination Technology Platform
Sylvia Martin University College Hospital London
Terry Durack Great Ormond Street Hospital
Tracy Coates Association for Perioperative Practice
Acknowledgements

v
ACDP-TSE RM [subgroup]: Advisory Committee on
Dangerous Pathogens Transmissible Spongiform
Encephalopathies Risk Management [subgroup]
(formerly the TSE Working Group)
ACDST: Advisory Committee on Decontamination
Science and Technology
AE(D): Authorising Engineer (Decontamination)
AP(D): Authorised Person (Decontamination)
BCH: Birmingham Childrens Hospital
BS: British Standard
BSE: Bovine Spongiform Encephalopathy
CFPP: Choice Framework for local Policy and
Procedures
CJD: Creutzfeldt-Jakob disease
CMO: Chief Medical Officer
CP(D): Competent Person (Decontamination)
CQC: Care Quality Commission
DH: Department of Health
DIPC: Director of Infection Prevention and Control
EDIC: episcopic differential interference contrast
EDIC/EF: episcopic differential interference contrast/
epifluorescence
EFSCAN: epifluorescent surface scanner
EN: European norm
FITC: fluorescein isothiocyanate
GOSH: Great Ormond Street Hospital
ISO: International Standards Organisation
MDD: Medical Devices Directive
MDR: Medical Devices Regulations
MHRA: Medicines and Healthcare products Regulatory
Agency
NDS: National Decontamination Survey
NICE: National Institute for Health and Clinical
Excellence
NICE IPG 196 (2006): NICEs (2006) interventional
procedure guidance 196 Patient safety and reduction
of risk of transmission of CreutzfeldtJakob disease
(CJD) via interventional procedures
OPA/NAC: o-phthalaldehyde/N-acetyl-L-cysteine
PO: posterior ophthalmic
sCJD: sporadic Creutzfeldt-Jakob disease
SSD: sterile services department
TSEs: transmissible spongiform encephalopathies
UCHL: University College Hospital London
vCJD: variant Creutzfeldt-Jakob disease
Abbreviations
vi
(CFPP) 01-01 offers best practice guidance on the whole
decontamination cycle including the management and
decontamination of surgical instruments used in acute
care.
Part A covers the policy, management approach and
choices available in the formulation of a locally
developed, risk-controlled operational environment.
The technical concepts are based on European (EN),
International (ISO) and British (BS) Standards used
alongside policy and broad guidance. In addition to the
prevention of transmission of conventional pathogens,
precautionary policies in respect of human prion diseases
including variant Creutzfeldt-Jakob disease (vCJD) are
clearly stated. Advice is also given on surgical instrument
management related to surgical care efficiencies and
contingency against perioperative non-availability of
instruments.
Part B covers common elements that apply to all methods
of surgical instrument reprocessing such as:
test equipment and materials
design and pre-purchase considerations
validation and verification.
Part C covers standards and guidance on steam
sterilization.
Part D covers standards and guidance on washer-
disinfectors.
Part E covers low temperature (non-steam) sterilization
processes (such as the use of vapourised hydrogen
peroxide gas plasmas and ethylene oxide exposure).
CFPP 01-01 Part A supersedes Health Technical
Memorandum 01-01 Part A (2006).
CFPP 01-01 Parts BE supersede Health Technical
Memoranda 2010, 2031 and Health Building Note 13
Supplement 1, and partially supersede Health Technical
Memorandum 2030. Only washer-disinfectors used for
processing surgical instruments (and not those used in
laboratories or for endoscopes) are covered in CFPP
01-01.
Executive summary
vii
Contents
Preface
Introduction
Purpose
Essential Quality Requirements and Best Practice
Acknowledgements
Abbreviations
Executive summary
1 Introduction 1
Structure of CFPP 01-01
2 Decontamination policy for reusable surgical instruments 4
The policy context
Essential Quality Requirements and Best Practice in decontamination
Developing a decontamination policy
Local determination of Best Practice
Implementation of CFPP 01-01
Examples of local choice
Keeping instruments moist and protein quantification using o-phthalaldehyde/
N-acetyl-L-cysteine (OPA/NAC) fluorescence
Revision of instrument set: design and management
Single instrument tracking and management using a commercial decontamination
services provider
Protein quantification using epifluorescence scanning
Protein quantification using episcopic differential interference contrast (EDIC)/
epifluorescence microscopy
3 Guidance for commissioners, regulators and providers 9
Implication for contractual agreements
Implication for third-party providers
4 Regulatory framework 11
European legislation
Compliance with the Medical Devices Regulations
Compliance with the MDD
Reusable medical devices transferred between legal entities
Reusable medical devices remaining within one legal entity
Outsourcing
The Health and Social Care Act 2008: Code of Practice
Key Code recommendations
Registration with the Care Quality Commission
British, European and International Standards
Policy and guidance
5 The evidence base: the risk from prion diseases and findings from the National Decontamination Survey 16
Risk from prion diseases
Why is there such concern about prion diseases?
Prion diseases and surgical instruments
Use of instruments on patients at risk of infection from prion diseases
viii
Summary for commissioners and regulators
Policy requirements for high prion transmission risk surgical instruments
Assessing risk in surgical procedures
Findings from the National Decontamination Survey
Findings
6 Management of surgical instruments 20
Introduction
Keeping instruments moist between use and reprocessing
Separation of instruments used on high risk tissues for patients born before and after 1
January 1997
Loan sets
Loan sets used in high-risk surgical procedures
Repairs
Instrument audit and tracking
Single-use instrument tracking and records
Decontamination of surgical instruments that have been dropped perioperatively
Staffing roles and responsibilities
Management definition
Executive Manager
Decontamination Lead
Designated Person
Surgical Instrument Manager/coordinator
Senior Operational Manager
User
Authorising Engineer (Decontamination) (AE(D))
Authorised Person (Decontamination) (AP(D))
Competent Person (Decontamination) (CP(D))
Director of Infection Prevention and Control (DIPC)
Infection Control Doctor
Microbiologist (Decontamination)
Operator
Manufacturer
Contractor
Purchaser
Competent Person (Pressure Systems)
7 Inactivation of prions using novel technologies 28
Appendix A: Reports from DH pilot studies concerning the implementation of NICE IPG 196 (2006)
guidance 29
Keeping instruments moist and protein quantification using OPA/NAC fluorescence
Aims and objectives
Methods and approaches for each component of these studies
Outcomes and benefits
Revision of instrument set: design and management
Aims and objectives
Method and approach
Pilot conclusions
Single-instrument tracking and management using a commercial decontamination service
provider
Aims and objectives
Method and approach
Pilot conclusions
Protein quantification using epifluorescence scanning
Aims and objectives
Method and approach
Pilot conclusions
Protein quantification using EDIC/ epifluorescence microscopy
Aims and objectives
Method and approach
Pilot conclusions
Appendix B: The National Decontamination Survey report 42
Appendix C: A patient and public perspective 43
Why the need for the guidance?
How does this affect me?
Am I at risk of CJD infection from surgical instruments?
What is being done to improve patient safety?
Appendix D: Standards relevant to decontamination 45
Standards relevant to decontamination processes and equipment
Standards relevant to decontamination management
Standards relevant to safety requirements for decontamination equipment
Standards relevant to medical devices
References 46
Contents
ix
x
1
1.1 Choice Framework for local Policy and Procedures
(CFPP) is a suite of best practice guidance that is
currently being piloted by the Department of
Health (DH) for England. The framework is
designed to reflect the need to improve efficiency
and outcomes in terms of safety, clinical
effectiveness and patient experience in line with
health policy direction.
1.2 This CFPP offers best practice guidance on the
management and decontamination of surgical
instruments used in acute care. The guidance
supports the Health and Social Care Act 2008:
Code of Practice for the prevention and control of
infections and related guidance (2010 revision),
and has been developed to strengthen local decision
making and accountability. This CFPP also
supports the vision for the NHS as set out in the
Health and Social Care Act 2012.
1.3 In order to be registered with the Care Quality
Commission (CQC), providers are required to
maintain appropriate levels of cleanliness and
hygiene in relation to reusable medical devices. The
Code of Practice provides guidance on how
providers can meet this registration requirement,
including key recommendations on the provision
of a safe decontamination service that generates a
clean and sterile product.
1.4 The Health and Social Care Act 2012 sets out the
Governments intention to ensure providers are
properly regulated, allowing them to work with
clinical commissioners to focus on improving
outcomes, be more responsive to patients and
innovate.
1.5 The Act also introduces a duty on the NHS
Commissioning Board and clinical commissioning
groups to secure continuous improvement in the
quality of outcomes achieved from health services.
These outcomes are to focus on the effectiveness,
safety and patient experience aspects of healthcare.
1.6 CFPP 01-01 supports local decision-making in the
commissioning, regulation, management, use and
decontamination of surgical instruments used in
acute care. The guidance is designed to support
continuous improvements in efficiency and
outcomes in terms of safety, clinical effectiveness
and patient experience by:
guiding care commissioners and regulators in
assessing the local policies and practices of a
provider in terms of their approach to the
instruments. Clear definitions of Essential
Quality Requirements and Best Practice are
provided in this CFPP, to help with this
assessment;
providing the evidence base and standards for
use by providers of care and those
decontaminating surgical instruments within
the NHS or commercially, to support them in
their decision-making process;
contributing to the effective management of
surgical instruments through all parts of the use
and reprocessing cycle (see Figure 1). This
includes management practices related to
surgical instruments in the theatre environment;
providing guidance for service-users and patient
groups on issues that are relevant to them. This
has been written to take account of
HealthWatchs future role in working with
providers, commissioners and quality regulators;
using the experience of recent pilot studies to
demonstrate new approaches to risk
management and to the implementation of the
National Institute for Health and Clinical
Excellences (NICE) interventional procedure
guidance 196 Patient safety and reduction of
risk of transmission of CreutzfeldtJakob disease
(CJD) via interventional procedures (hereafter
referred to as NICE IPG 196 (2006)). (See
Appendix A: Reports from DH pilot studies
concerning the implementation of NICE IPG
196 (2006) guidance.)
1 Introduction
2
Note
Regulators include the CQC, the Medicines and
Healthcare products Regulatory Agency (MHRA), and
notified bodies.

1.7 With CFPP 01-01, the DH is seeking to establish:
the prevention and control of the risk of
transmission of infection through surgical
instruments with specific reference to the
theoretical risk of human prion diseases
transmission (transmissible spongiform
encephalopathies, or TSEs);
a comprehensive approach to risk control and
reduction across instrument management and
decontamination;
assurance over the management of surgical
instruments, in terms of availability, quality and
suitability;
the preservation and advance of high-quality
engineering through the support of European
Norms (ENs), quality systems and standards;
guidance for optimisation of the environment,
equipment and facilities used in surgical
decontamination.
1.8 CFPP 01-01 refers to NICE IPG 196 (2006) and
guidance derived from the Advisory Committee on
Dangerous Pathogens Transmissible Spongiform
Encephalopathies Risk Management (ACDP-TSE
RM) subgroup (formerly the TSE Working group)
throughout. It draws on the findings of the
National Decontamination Survey (NDS) (2008
2010) to highlight aspects of decontamination
management practice that need addressing, and
presents findings from NDS pilot studies to suggest
ways in which decontamination management
practices can be developed.
1.9 Management recommendations centre on:
improving instrument set integrity
ensuring that a separate pool of new
neuroendoscopes and reusable surgical
instruments is available for high risk procedures
on patients born since 1 January 1997, as it is
thought that people born since 1 January 1997
ACQUISITION
1. Purchase
2. Loan
CLEANING
TRANSPORT
TRANSPORT
STERILIZATION
PACKAGING
DISPOSAL
1. Scrap
2. Return to lender
At all stages:
Location
Facilities
Equipment
Management
Policies/Procedures
INSPECTION
(& PROTEIN TESTING)
DISINFECTION
USE
STORAGE
The reusable surgical
instrument cycle
(NEW PRION DEACTIVATION
TECHNOLOGY)
Figure 1 The reusable surgical instrument cycle
1 Introduction
3
have had lower exposure to prions via the food
chain or blood transfusion;
ensuring contingency for dropped or
unavailable instruments;
ensuring a continuously moist environment for
instruments between use and reprocessing;
ensuring maximum efficiency in protein
removal (see Appendix A: Reports from DH
pilot studies concerning the implementation of
NICE IPG 196 (2006) guidance);
having a system in place for surgical instrument
management and to cover the quality, condition
and suitability of reusable surgical instrument.
1.10 Whether decontamination services are provided by
the healthcare provider or from an external source,
the requirements of the instrument management
and decontamination policy outlined in this
guidance should be followed.
1.11 CFPP 01-01 Part A supersedes Health Technical
Memorandum (HTM) 01-01 Part A (2006).
Structure of CFPP 01-01
1.12 CFPP 01-01 Part A covers the policy, management
approach and choices available in the formulation
of a locally developed, risk-controlled operational
environment.
1.13 The technical concepts are based on European
(EN), International (ISO) and British (BS)
Standards used alongside policy and broad
guidance. In addition to the prevention of
transmission of conventional pathogens,
precautionary policies in respect of human prion
diseases including variant Creutzfeldt-Jakob disease
(vCJD) are clearly stated. Advice is also given on
surgical instrument management related to surgical
care efficiencies and contingency against
perioperative non-availability of instruments
1.14 Part B covers common elements that apply to all
methods of surgical instrument reprocessing such
as:
test equipment and materials
design and pre-purchase considerations
validation and verification.
1.15 Part C covers standards and guidance on steam
sterilization.
1.16 Part D covers standards and guidance on washer-
disinfectors.
1.17 Part E covers low temperature (non-steam)
sterilization processes (such as the use of vapourised
hydrogen peroxide gas plasmas and ethylene oxide
exposure).
4
2.1 A safe decontamination service contributes to
successful clinical outcomes and the wellbeing of
patients and staff. Healthcare providers in England
are required by law to comply with essential levels
of safety and quality which are assessed by the
CQC. These levels are set in law through
registration requirements, one of which covers
cleanliness and infection control. Guidance on
meeting this registration requirement is provided
by the Health and Social Care Act 2008: Code of
Practice on the prevention and control of infections
and related guidance. The Code of Practice
recommends that healthcare organisations comply
with guidance establishing Essential Quality
Requirements and demonstrate that a plan is in
place for progression to Best Practice.
2.2 CFPP 01-01 draws on DH policy and current
advice to provide comprehensive guidance on the
instruments used in acute care. This includes clear
definitions of what constitutes Essential Quality
Requirements and Best Practice.
2.3 In acute care, precautionary policies in respect of
human prion diseases including vCJD also apply.
2.4 This guidance therefore seeks to offer advice across
a range of risk types. Specifically, these include:
The risk of infection via surgical instruments.
The theoretical but potentially highly significant
risk of transmission of human prion diseases
including, but not limited to, vCJD.
The availability, quality and suitability of
surgical instruments.
Interruption to, or abandonment of, surgery
where this is due to instrument quality, the
absence of key instruments from the surgical set
or, in very rare instances, where an instrument
has been dropped perioperatively or otherwise
has had its sterility compromised during use.
2.5 In this CFPP, a number of options are offered for
dealing with risks highlighted by the NDS (2008
2010). These options are outlined based on
experience gained from pilot studies and guidance,
and include information on the observed outcomes.
As experience grows, individual reports and
findings will be incorporated.
2.6 See Appendix B: The National Decontamination
Survey report.
The policy context
2.7 CFPP 01-01 is best practice guidance, which has
been developed from the following policy
initiatives.
2.8 The Health and Social Care Act 2012 sets out the
framework for the governments vision for
modernising the NHS. It gives power to clinicians
to make commissioning decisions, and gives more
choice and control to patients. It also establishes
Monitor as a strong service regulator to act in the
interests of patients.
2.9 The NHS Commissioning Board will continue to
look to providers to deliver services that enhance
patient safety and the patient experience, and that
deliver value for money. Part of this is a drive
towards constant assurance of correctly selected,
clean, sterile and fully functioning surgical
instruments at the point of care delivery.
2.10 The management and decontamination of surgical
instruments are key components in the delivery of
safe interventional care. This guidance advocates a
full assessment of the volume and types of surgical
service provided, the turnaround times required for
decontamination, the prion transmission risks
associated with the tissues encountered in each area
of service, and the instrument stock required for
onsite and offsite decontamination. To gain a full
understanding of the risks involved, including the
risk of prion disease transmission, see paragraph
5.1, Risk from prion diseases.
2.11 In light of this, CFPP 01-01 advocates that
commissioners, providers and regulators adopt a
risk-control approach to the management of single-
2 Decontamination policy for reusable surgical
instruments
2 Decontamination policy for reusable surgical instruments
5
use instruments and to the management and
decontamination processes for reusable surgical
instruments, in line with the essential requirements
of the Medical Devices Directive (MDD) and the
ENs that support them (see Chapter 4, Regulatory
framework).
Essential Quality Requirements and
Best Practice in decontamination
2.12 Essential Quality Requirements, for the purposes
of this best practice guidance, is a term that
encompasses all existing statutory and regulatory
requirements. Essential Quality Requirements
incorporate requirements of the current MDD and
approved Codes of Practice as well as relevant
applicable Standards. They will help to demonstrate
that an acute care service provider operates safely
with respect to the management and
decontamination of instruments.
2.13 Attainment of Essential Quality Requirements
should also include a local risk-assessment for
surgical instrument management, encompassing
the provision of instruments that are safe to use and
the reliable provision of all required instruments.
2.14 Local policy should define how a provider achieves
risk control and what plan is in place to work
towards Best Practice.
2.15 Local policy development that takes account of this
CFPP guidance could result in amended theatre
practices, such as improvements to the audit trail
for instruments and the provision of instruments
sets that do not require the use of supplementary
instruments (for example, see Appendix A
paragraph A45).
2.16 Comparison of local policy statements and quality
systems with audit results will confirm attainment
of Essential Quality Requirements and progression
towards Best Practice. Such assessment could
provide a mechanism for differentiating between
care providers in commissioning services.
2.17 Best Practice is additional to the Essential Quality
Requirements. Best Practice as defined in this
guidance covers non-mandatory policies and
procedures that aim to further minimise risks to
patients; deliver better patient outcomes; promote
and encourage innovation and choice; and achieve
cost efficiencies.
2.18 Best Practice should be considered when
developing local policies and procedures based on
the risk of surgical procedures and available
evidence. Best Practice encompasses guidance on
the whole of the decontamination cycle, including,
for example, improved instrument management,
where there is evidence that these procedures will
contribute to improved clinical outcomes.
Developing a decontamination policy
2.19 In the context of this CFPP, decontamination
policy is dependent on the types of surgical
procedure undertaken and determined by the staff
involved with the management and
decontamination of reusable surgical instruments.
It is recommended that staff conduct a local risk
assessment, record their local policy, and adopt and
develop procedures appropriate to their services.
The policies and procedures selected should meet
Essential Quality Requirements or exceed them by
achieving Best Practice. Figure 2 illustrates the
drivers for improvements and desired outcomes.
2.20 This applies to decontamination facilities on and
off healthcare premises and in decontamination
services managed by independent healthcare
providers.
2.21 For the key elements of a decontamination policy,
see paragraph 4.25, The Health and Social Care
Act 2008: Code of Practice.
Local determination of Best Practice
2.22 To assess Best Practice, a local risk assessment group
may be set up. This group could assess
decontamination option requirements and consider
what aspects of Best Practice should be
implemented, based on improving patient
outcomes, decontamination benefits, efficiencies
and risks, including those prion risks as defined by
the ACDP-TSE Risk Assessment subgroup.
2.23 A Director of Infection Prevention and Control
(DIPC) will have ultimate responsibility for the risk
assessments. Others included in the group could
be:
the DIPCs designated appointee;
the decontamination lead;
the surgical instrument manager;
representative(s) from the Infection Control
Team;
representative(s) from the clinical device users;
the User;
6
an Authorising Engineer (Decontamination).
2.24 For a brief summary of staffing roles and
responsibilities, see paragraph 6.34, Staffing roles
and responsibilities.
2.25 Others, such as representatives of decontamination
services and estates and facilities, may be members
of the group or co-opted at the discretion of the
DIPC.
Implementation of CFPP 01-01
2.26 This guidance will help providers to achieve a
satisfactory level of risk control together with
compliance with the essential requirements of the
Medical Devices Regulations (MDR).
2.27 This guidance recommends that all providers of
surgical care work with their decontamination
specialists to achieve Essential Quality
Requirements and a locally risk-assessed
progression to Best Practice. Not all service
providers will be in a position to adopt Best
Practice recommendations. However, every service
provider will need to:
assess what Best Practice is appropriate for each
of the decontamination settings in their control,
based of the surgical procedures undertaken;
what improvements they need to undertake to
move towards these; and
prepare a plan for progression to Best Practice.
2.28 All units where surgical instruments are used or
decontaminated should be working at or above
Essential Quality Requirements and have in place
local policies and business development
programmes that demonstrate progression to Best
Practice.
2.29 This guidance has been developed and validated by
a series of pilot studies in England and Scotland,
which looked primarily at the feasibility and
practicality of implementation. The lessons learned
form an important part of this CFPP (see
Examples of local choice, following).
Examples of local choice
2.30 DH-funded pilot studies have been active in
addressing a number of key risk-reduction
alternatives. Principally these include:
Maintaining instruments in a moist
environment following use and before
reprocessing.
The retention of surgical instruments within
their sets by the application of both individual
instruments and set level track and trace
technologies.
Revision of set contents in neurosurgery in
order to obtain enhanced suitability for purpose
ACTIONS BEST PRACTICE OUTCOMES
Amended theatre
and decontamination
techniques
Management of
services and clinical
instruments
Audit trail of
instruments
ESSENTIAL
QUALITY
REQUIREMENTS
Local policies and
procedures
Quality systems in place to
demonstrate compliance
with the Essential
Requirements of the
Medical Devices Directive
(MDD)
Plan to work towards
Best Practice
Continuous improvements
LOCAL CHOICE
IMPROVED
PATIENT
OUTCOMES
COST
EFFICIENCIES
ENHANCED
PATIENT
EXPERIENCE
Scientific and
technical framework
European Norms
ISOs
National Decontamination
Survey
Policy framework
2007 clarification
Health and Social Care
Act 20102012
NICE risk-control guidance
Advisory Committee
risk-management guidance
Legal framework
Consumer legislation
Medical Devices Directive
(EU)
Medical Devices
Regulations (UK)
Health Act Code of
Practice
DRIVERS FRAMEWORK
Evidence base
and standards
Patient safety
Outcome-focus
Risk control

Patient safety
Staff safety
Figure 2 Choice Framework for local Policies and Procedures Management and decontamination of reusable surgical instruments: Drivers for
quality improvements and desired outcomes
2 Decontamination policy for reusable surgical instruments
7
and reduced set instrument leakage when
combined with set colour codes.
Strategies for the purchase, set design and
application of instruments used in paediatric
high-risk surgery for patients born after 1
January 1997.
The development and evaluation of protein
detection and quantification techniques for use
with instruments following washing and
disinfection.
The maximisation of protein removal by the use
of suitably optimised washer-disinfector and
detergent systems.
2.31 The following pilot-study summaries are provided
as possible examples of local choice (for the full
reports, see links in each section).
Keeping instruments moist and protein
quantification using o-phthalaldehyde/ N-acetyl-
L-cysteine (OPA/NAC) fluorescence
2.32 This collaboration between Great Ormond Street
Hospital (GOSH), University College Hospital
London (UCLH) and Queen Mary University of
London aimed to investigate several aspects of
instrument management and decontamination.
These included implementation of NICE IPG 196
(2006) guidance on reducing instrument migration
and separate pooling of instruments for patients
born after 1 January 1997, keeping instruments
moist prior to reprocessing, research into enhanced
protein detection, and optimisation of washer-
disinfector performance.
2.33 NICE IPG 196 (2006) guidance has been
successfully implemented through the introduction
of single-instrument tracking and tray level tracing,
via GS1 coding and matrix marking of instruments
with scanning at various points throughout the use/
reprocessing cycle. This has also enabled effective
segregation of new instruments for patients born
after 1 January 1997, supported by protocols to
determine who may have access to these
instruments.
2.34 An OPA/NAC fluorescence-based digital image
capture system has been developed that provides
increased sensitivity and quantification of residual
protein on reprocessed instruments. This system
has demonstrated a five-order of magnitude
improvement in protein removal when moist,
compared with test pieces allowed to dry after use.
Experiments with different washer-disinfector
chemistries and item positions show that there is
considerable variation in efficacy associated with
both variables. See Appendix A paragraph A2,
quantification using OPA/NAC fluorescence.
Revision of instrument set: design and
management
2.35 This pilot was undertaken at Newcastle upon Tyne
Teaching Hospitals NHS Trust to investigate the
prevention of migration of neurosurgical
instruments between sets using single-instrument
tracking via GS1 coding. However, initial trials
were cumbersome and indicated that there were
high levels of instrument leakage occurring,
possibly connected to high levels of supplementary
instrument use. The project was therefore revised to
focus on the suitability of the instrument sets for
the intended surgery.
2.36 A substantial revision to set contents resulted in
fewer but larger instrument sets and has largely
eliminated the need for supplementary
instruments. Where sets have become too large for
easy handling, they have been split among multiple
caskets with GS1 coding employed to track at tray
and set level, with some selective use of individual
instrument tracking. As a result, instrument leakage
has dropped to negligible levels. Colour-coded
casket lids distinguish high-risk sets from general
sets as well as those sets reserved for patients born
after 1 January 1997. These techniques are
supported by audit procedures and have proven
simple to administer and robust in practice. See
Appendix A paragraph A45, Revision of
instrument set: design and management.
Single instrument tracking and management using
a commercial decontamination services provider
2.37 The Birmingham Childrens Hospital NHS Trust
has been working with its decontamination services
provider to implement NICE IPG 196 (2006)
guidance in the context of an external commercial
decontamination service contract. The key aspects
addressed are limitation of instrument migration
through single-instrument tracking of neurosurgical
instruments and the maintenance of separate
instrument sets for patients born after 1 January
1997.
2.38 Instruments have been uniquely marked with
matrix codes that relate to GS1 identifiers, though
there are issues over the durability of these marks
8
on some of the smaller instruments where the code
has to be restricted to a very small area. Software
upgrades have been put in place to support the
single-instrument tracking; protocols for its use
have been developed by both the trust and the
decontamination services provider. Tracking of the
instruments will also enable tracing to patients
(within the trust only), enhancing a manual paper-
based system.
2.39 New sets of neurosurgical instruments for patients
born after 1 January 1997 have been purchased and
marked. An identification system, involving colour
coding of the handles of each instrument in these
sets, had been explored but has not been
implemented on microbiological advice. The set
labelling also included the text: post 1997. See
Appendix A paragraph A65, Single-instrument
tracking and management using a commercial
decontamination service provider.
Protein quantification using epifluorescence
scanning
2.40 A sensitive fluorescence-based scanning technique
developed at the University of Edinburgh allows
analysis of reprocessed surgical instruments from
the Royal Infirmary of Edinburgh to be assessed for
the distribution and concentration of protein.
2.41 The compact bench-top scanner unit, driven by a
standard PC, is suitable for use in a sterile services
department (SSD). A combination of
measurements from instruments provided by the
Royal Infirmary were used to develop a traffic
light system to enable SSD staff to accept scanned
instruments as being clean and fit for reuse.
Comparisons against a visual validation process
used with washerdisinfectors have been carried
out. Further software development of the user
interface, particularly in respect of presenting hot
spot contamination information, plus scanning
optimisation is ongoing, as is work on establishing
both current ranges of protein contamination on
surgical instruments and target ranges for improved
decontamination processes. See Appendix A
paragraph A85, Protein quantification using
epifluorescence scanning.
Protein quantification using episcopic differential
interference contrast (EDIC)/epifluorescence
microscopy
2.42 Work using a novel microscope-based fluorescence
technique, developed by the University of
Southampton, has enabled sensitive measurement
of general proteins and specifically plaque
proteins associated with vCJD on reprocessed
surgical instruments than can be detected using
established swab-based tests. This technique
correlates with other studies to show that visual
assessment of the contamination on reprocessed
instruments can be extremely inaccurate.
2.43 Tests on commercial chemistries used in SSD
washer-disinfectors have shown that none are fully
effective against protein contamination and that
there is a wide range of efficacy between products.
Tests on surgical instruments passing through the
SSD at Southampton General Hospital are in
progress and will provide more detailed
information about the effectiveness of the process,
in parallel with conventional testing. See Appendix
A paragraph A97, Protein quantification using
EDIC/epifluorescence microscopy.
9
3.1 The overarching aim of the commissioning
function is to ensure the highest levels of patient
care and staff safety, in the most cost-effective
manner. In commissioning decontamination
services for surgical instruments used in acute care,
commissioning organisations should aim to deliver:
sustainable high standards of patient safety;
improved clinical care outcomes arising from a
carefully considered local instrument
management strategy;
an enhanced patient experience through
minimising delay and procedure cancellations
associated with instrument provision;
cost efficiencies from instrument provision to
the demands of the care given;
local choice in the means of risk control both
through instrument management and in choices
with regard to decontamination;
appropriate quality systems and engineering
standards;
professional work by trained managers and staff
throughout the reusable surgical instrument
cycle.
See the NHS Operating Framework 2012/13 for
further guidance on the new commissioning and
management system for the NHS.
3.2 Responsibility for achieving acceptable standards of
decontamination rests with commissioning
organisations, individual trusts and provider
organisations. Reprocessing units in healthcare
establishments responsible for the decontamination
of medical devices fall into two distinct categories
when considering compliance with the MDD:
Devices transferred between legal entities (for
example reprocessing by one entity followed
by use in another).
Devices remaining within one legal entity (for
example reprocessing and use by the same
entity or organisation).
For further information, see paragraph 4.5,
Compliance with the Medical Devices Regulations.
3.3 When commissioning surgery, commissioning
organisations should require that the healthcare
provider is receiving devices, or it has a
decontamination service, that meets the essential
requirements of the MDR and is able to
demonstrate evidence of an appropriate quality
management system and audit system.
3.4 Commissioning organisations should also expect
the healthcare provider to have a plan in place to
achieve Best Practice. This plan should have been
developed, having taken account of the risk of
surgical procedures (see paragraph 2.19,
Developing a decontamination policy and
Chapter 5, The evidence base: The risk from prion
disease and findings from the National
Decontamination Survey). Commissioning
organisations may use this plan to improve the
services commissioned from providers for the
benefit of patients, and to differentiate between
providers.
3.5 They may do this by:
including the attainments within the service
specification element of the standard contract;
establishing key performance indicators as part
of a tendering process; and
using Best Practice as an incentive to improve
provider performance.
3.6 Best Practice could also be used as attainment levels
against which improvements can be measured and
rewarded, enabling commissioners to encourage
evidence-based practices and innovation.
3.7 Providers may refer to paragraph 2.12, Essential
Quality Requirements and Best Practice in
decontamination in order to assess the quality of
3 Guidance for commissioners, regulators and
providers
10
their decontamination services and demonstrate
quality improvement within their organisation.
3.8 In the event of poor performance, commissioners
may discuss the level of performance with their
providers and address any issues and concerns
before introducing more formal contractual
remedies.
3.9 Regulators may use the recorded risk-assessed local
policy to check Essential Quality Requirements
attainments alongside adherence to regulatory
requirements.
Implication for contractual agreements
3.10 The adoption of a risk-control based approach to
surgical instrument management should not
prejudice current contractual agreements. While
there is sufficient flexibility in current contractual
arrangements to accommodate the CFPP approach,
the development of local policies and procedures
may require locally negotiated variations to the
contract to accommodate changes to the service
specification. There are two routes to vary the
contracts let through the National
Decontamination Programme: via schedule 11 and
schedule 21 of the Decontamination Services
Agreement. For other third-party contracts, advice
would have to be sought locally on the mechanism
for implementing changes.
Implication for third-party providers
3.11 Where decontamination services are provided by a
third party, all parties to the service should work
together to develop local policies and procedures
that are appropriate and can be implemented.
3.12 It should be noted that third-party providers of
decontamination services come under the MDD
(directive 93/42/EEC has been superseded by
directive 2007/47/ EC). They will be using existing
British and European Standards to demonstrate
compliance with the essential requirements of the
MDD and will have a quality system against which
they are independently audited. The development
and implementation of new local policies and
procedures may require a variation to the contract
and changes to quality systems to accommodate.
11
4.1 This chapter sets out the duty of care for
decontamination services in England. The
regulatory framework is applicable across all sectors
of healthcare (see Figure 3).

Figure 3 Overview of the interaction between the different structures
within the English legislative system
4 Regulatory framework

NICE guidance (e.g. NICE196)
ACDP-TSE-RM guidance
English Legislation (this is not an exclusive list)
Health and Social Care Act 20102012
Health and Social Care Act 2008 (Regulated Activities
Regulations 2010
Health Act 2009
Health and Safety at Work etc Act 1974
Consumer Protection Act 1997
Health and Social Care (Community Health and Standards) Act
2003
Regulations and Codes of Practice relating to the manufacture and supply of medical devices and reprocessing
equipment
Medical Devices Regulations 2002
Pressure Systems Safety Regulations 2000 (as amended)
Control of Substances Hazardous to Health Regulations 2002 (as amended)
Personal Protective Equipment at Work Regulations 1992 (as amended)
Te Health and Social Care Act 2008: Code of Practice on the prevention and control of infections and related
guidance
Healthcare Standards
Regulatory bodies
Care Quality Commission
Regulatory bodies
Medicines and Healthcare products Regulatory
Agency (MHRA)
Notifed bodies
European Legislation
(eg European Directives)
Medical Devices Directive 93/42/EEC
In-Vitro Diagnostic Devices Directive
1
Active Implantable Medical Devices Directive
1
British, European and International
Standards
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DH Guidance (CFPPs and Health Building
Notes such as HBN 13)
MHRA guidance (safety notices, alerts and
bulletins)

Notes
1. Te In-Vitro Diagnostic Devices and Active
Implantable Medical Devices Directives have
been included for completeness although these
devices are usually supplied sterile and are
single-use.
G
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P
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12
European legislation
4.2 There are three EU Directives relating to the
manufacture and supply of medical devices:
MDD 93/42/EEC
In-vitro Diagnostic Devices Directive 98/79/
EEC
Active Implantable Medical Devices Directive
90/385/EEC.
4.3 These three directives have been transposed into
UK law as the Medical Devices Regulations
(MDR) 2002, as amended. (For more information
about the MDDs and compliance, visit the
MHRAs website.)
4.4 Washer-disinfectors and sterilizers that is, those
machines specifically intended for the
decontamination of reusable medical devices can
also fall within the scope of the MDR.
Compliance with the Medical Devices
Regulations
4.5 Only those units that transfer reusable medical
devices between legal entities are within the scope
of the MDD and the MDR.
4.6 Devices decontaminated for reuse within the same
legal entity or trust are not placed on the market
and are therefore outside the scope of the
regulations.
4.7 Irrespective of this, however, the standards applied
to all organisations that provide decontamination
services are monitored against the essential
requirements of the MDD. This is undertaken
either by a notified body, whose activities are
monitored by the MHRA if the formal certification
route is applied, or by the CQC.
4.8 Figure 4 illustrates the regulatory framework and
the compliance routes for reusable medical devices
transferred between legal entities and for reusable
medical devices remaining within one legal entity.
Compliance with the MDD
4.9 Responsibility for achieving acceptable standards of
decontamination rests with commissioners,
individual trusts and provider organisations.
4.10 Healthcare organisations decontaminating reusable
medical devices fall into two distinct categories
when considering compliance with the MDD:
reusable medical devices transferred between
legal entities
Figure 4 Regulation and audit of decontamination services and the respective responsibilities of MHRA and CQC
13
reusable medical devices remaining within one
legal entity.
4.11 The requirement for formal certification of SSDs
under the MDD is dependent on whether
product is placed on the market. Providing
products to another legal entity is placing product
on the market.
4.12 The implications of the MDD regulations are that
all those organisations that provide
decontamination services and which place product
on the market are legally required to demonstrate
compliance to the harmonised standards contained
within the directive. It provides a standardised
approach to decontamination in the UK and across
all European countries.
4.13 The most commonly used route to demonstrating
compliance is to institute a quality management
system such as BS EN ISO 13485 across all areas of
the decontamination cycle.
4.14 BS EN ISO 13485 specifies requirements for a
quality management system that can be used by a
healthcare organisation for the design and
development, production, installation and servicing
of reusable medical devices and the design,
development and provision of related services. It
can also be used by internal and external parties,
including certification bodies, to access the
healthcare organisations ability to meet customer
and regulatory requirements. Its primary objective
is to facilitate reusable medical device regulatory
requirements for quality management systems.
Reusable medical devices transferred between
legal entities
4.15 Healthcare organisations offering the
decontamination of reusable medical devices to
another legal entity are subject to the requirements
of the MDR. If sterile devices are produced, the
intervention of a third-party audit programme
must also be undertaken by a recognised notified
body.
4.16 A notified body is a certification organisation that
the competent authority (MHRA within the UK)
designates to carry out one or more of the
conformity assessment procedures described in the
annexes of the MDR.
4.17 Healthcare organisations placing product on the
market must also register with the MHRA.
4.18 Commissioners should be provided access, if
required, to check that a provider is registered with
a notified body and has an appropriate quality
system in place.
4.19 Commissioners should be given access to the results
of the most recent third-party (notified body) audit
and should be able to see any:
non-conformances picked up in the audit;
required corrective actions that have been
agreed; and
evidence of corrective actions being
implemented.
Reusable medical devices remaining within one
legal entity
4.20 If a healthcare organisation only provides
decontaminated reusable medical devices for use
on, or by, patients of that same entity (that is, there
is no placing on the market), the MDR do not
apply.
4.21 These healthcare organisations do not need to
register with the MHRA nor do they need to use a
notified body; nevertheless, they are subject to the
duty of care imposed under product liability. They
must still ensure instruments are safe, fit for
purpose and of suitable quality. The CQC will
assess the performance of these organisations.
Registration with the CQC includes a number of
requirements in this area, and providers are
required to comply with these requirements.
4.22 Compliance with BS EN ISO 13485 will
demonstrate a commitment to producing reusable
medical devices of appropriate quality.
Outsourcing
4.23 The options for those healthcare organisations that
do not undertake decontamination services include:
Using a decontamination service that is
registered with the MHRA, that is compliant
with the MDR, and that uses a notified body as
its third-party auditor.
Using CE-marked single-use medical devices.
4.24 The relative merits of the options should be evident
through developing a business case highlighting the
options, timescales, cost benefits and reliability
assessment.
14
The Health and Social Care Act 2008:
Code of Practice
4.25 The guidance provided here is consistent with the
Health and Social Care Act 2008: Code of Practice
on the prevention and control of infections and
related guidance 2010 revision (the Code). The
Code recommends that effective prevention and
control of healthcare-associated infections be
embedded in everyday practice. For this reason, the
guidance is written with emphasis on practical and
readily implemented measures.
4.26 Adhering to this CFPP will assist providers in
complying with the decontamination guidance set
out in the Code and in meeting the CQC
registration requirement on hygiene and infection
control.
Key Code recommendations
4.27 With a view to minimising the risk of infection, a
registered provider should normally ensure that it
designates leads for environmental cleaning and
decontamination of equipment used for diagnosis
and treatment (a single individual may be
designated for both areas).
4.28 The decontamination lead should have
responsibility for ensuring that policies exist and
that they take account of best practice and national
guidance for the decontamination of reusable
4.29 The decontamination policy should demonstrate
that:
it complies with guidance establishing Essential
Quality Requirements and a plan is in place for
progression to Best Practice;
decontamination of reusable medical devices
takes place in appropriate facilities designed to
minimise the risks that are present;
appropriate procedures are followed for the
acquisition, maintenance and validation of
decontamination equipment;
staff are trained in cleaning and
decontamination processes and hold appropriate
competences for their role; and
a record-keeping regime is in place to ensure
that decontamination processes are fit for
purpose and use the required quality systems.
(See also Outcome 11, Regulation 16 Safety,
availability and suitability of equipment
contained in CQC Guidance about
compliance.)
Registration with the Care Quality
Commission
4.30 The Care Quality Commission (CQC) regulates all
providers of regulated health and adult social care
activities in England.
4.31 The CQCs role is to provide assurance that the
care given meets essential requirements of quality
and safety.
4.32 The registration requirements are set out in the
Health and Social Care Act 2008 (Regulated
Activities) Regulations 2010 and include
requirements relating to:
safety and suitability of premises;
safety, availability and suitability of equipment;
and
cleanliness and infection control.
4.33 The CQC is responsible for developing and
consulting on its methodology for assessing
whether providers are meeting the registration
requirements (see the CQCs Guidance about
compliance (2010)). Failure to comply with the
requirements is an offence, and under the 2008
Act, CQC has a wide range of enforcement powers
that it can use if the provider is not compliant.
These include the issue of a warning notice that
requires improvement within a specified time,
prosecution, and the power to cancel a providers
registration, removing its ability to provide
regulated activities.
British, European and International
Standards
4.34 To support the MDD and to assist manufacturers
(including decontamination services) to interpret
the essential requirements, the European
Commission has published an updated list of
harmonised standards. Compliance with all
relevant harmonised standards on this list leads to
an automatic presumption that the medical devices
comply with the requirements of the MDD.
4.35 Although compliance with a mandated standard is
not the only way of complying with the directives,
it is the simplest.
4.36 The list of standards given in Appendix D is not
exhaustive but includes the key documents that
15
may be used to inform the management of
decontamination of reusable medical devices in a
healthcare organisation. See also the website of the
European Union.
Policy and guidance
4.37 The DH and other professional bodies and
advisory committees have published guidance on
the decontamination of surgical instruments. The
list below is not exhaustive but includes the key
resources that may be used to inform the
management of decontamination within a health
service environment:
The DHs CFPP series.
For a list of medical device alerts, safety notices,
hazard notices and device bulletins relating to
decontamination, visit the MHRAs website.
4.38 The DHs policy is that the measures defined in
NICE IPG 196 (2006) guidance be incorporated
into practice and supplemented by the guidance
derived from the ACDP-TSE RM subgroup:
ACDP-TSE RM provides practical scientifically
based advice on the management of risks from
TSEs in order to limit or reduce the risks of
human exposure to, or transmission of, TSEs in
healthcare and other occupational settings.
NICE IPG 196 (2006) provides guidance on
how best to manage the risk of transmission of
CJD and vCJD via interventional procedures.
This was the subject of CMO Letters
recommending the implementation of NICE
IPG 196 (2006) and is DH policy.
16
Risk from prion diseases
5.1 Management and decontamination of surgical
instruments policy and supporting guidance is
closely linked to reducing or preventing the risk of
transmission of prion diseases.
5.2 Prion diseases are rare, fatal, degenerative
conditions of the central nervous system (brain and
spinal cord) that affect humans and certain other
animals. Until 1986 few people had heard of them
but that changed with the appearance of Bovine
Spongiform Encephalopathy (BSE) or mad cow
disease.
5.3 In 1996 it was confirmed that BSE had been
transmitted to humans via contaminated beef
products. This was a new condition in humans and
was called vCJD.
5.4 This name was chosen to differentiate the new
condition from sporadic CJD (sCJD), a very rare
human prion disease that had been known for
nearly a century and which usually affects people
aged over 60 years.
5.5 So far there have been fewer than 200 cases of
vCJD diagnosed in the UK, with smaller numbers
in other countries. In contrast to sCJD, the median
age at onset of vCJD is only 28 years.
5.6 Although some cases of CJD seem to occur
spontaneously, it is possible to infect laboratory
animals by inoculating them with brain tissue taken
from another infected animal or source of human
infection. BSE and other prion diseases have also
been shown to be transmissible in this way. Some
of this experimentation involves the use of CJD
contaminated test wires or spheres that are used to
model surgical instruments and are made from the
same materials.
5.7 As a result of the above properties, CJDs are often
referred to as TSEs.
5.8 A very small number of cases of sCJD have
occurred following procedure using surgical
instruments (including electrodes) that had
previously been used in surgery on the brain of
someone subsequently shown to be suffering with
CJD. This occurred despite the instruments having
been decontaminated and sterilized using
conventional methods. This is because the
infectious agent believed to cause prion diseases (a
misfolded or abnormal version of a normal cellular
protein PrP) is very hard to destroy.
5.9 Some forms of CJD are hereditary, meaning that
they are passed down from generation to
generation, and some occur because of genetic
mutations. There is an even rarer human prion
disease called Gerstmann-Strussler-Scheinker
disease (GSS), which is a genetic condition and
causes a condition very similar to sCJD.
5.10 A key feature of prion diseases is that they can have
extensive incubation periods after exposure to the
infectious agent, sometimes measured in years.
5.11 In recent years a number of cases of vCJD have
occurred in patients who received blood
transfusions from donors who themselves later
went on to develop vCJD. To date all those patients
tested, with one possible exception, have
homozygous MM DNA bases at Codon 129 of the
PrP gene. Thus there may be a link between
susceptibility and genetic status
5.12 To summarise, prion diseases are rare but fatal.
They affect the brain. They can occur
spontaneously; be hereditary; or can occur as a
result of genetic mutation. They are caused by an
agent that is very hard to destroy. They can be
transmitted from one animal (including humans)
to another by inoculation.
5.13 The DH takes a precautionary approach in this
area of disease transmission. That is, the risk of
prion transmission should be minimised within the
constraints of current knowledge.
5 The evidence base: the risk from prion
diseases and findings from the National
Decontamination Survey
5 The evidence base: the risk from prion diseases and ndings from the National Decontamination Su
17
Why is there such concern about prion
diseases?
5.14 So far, the number of known transmissions of prion
disease from one human to another is very small.
CJD in its classical (or sporadic) form is the most
common of the human TSEs, but it is still rare,
with an annual incidence worldwide of around one
case per million population (Hilton and Ironside,
2003).
5.15 However, vCJD differs from sCJD and the other
human prion diseases in two important areas:
Significant infectivity can be found in tissues
other than the brain.
Surveys suggest that many thousands of people
might be symptom-free but infected.
5.16 Since it was first described there have been over
170 deaths from definite or probable cases of vCJD
in the UK. The peak year for deaths was 2000,
since when numbers of cases per annum have fallen
but not ceased.
5.17 Currently, there is no reliable screening test that
can be used to identify people infected with vCJD,
though research is ongoing, neither is a cure
available.
5.18 This, plus the fact that standard methods of
decontaminating surgical instruments cannot
reliably fully deactivate or destroy the infectious
agent causing the disease, raises the possibility that
vCJD could be transmitted via certain healthcare
interventions.
5.19 The DHs precautionary principle, to ensure that
the risk of prion transmission is minimised within
the constraints of current knowledge, underpins
much of what is contained in this guidance.
Prion diseases and surgical instruments
5.20 The abnormal protein that occurs in prion diseases
accumulates in various tissues.
5.21 In both sCJD and vCJD the highest levels occur in
the central nervous system (intradural operations
on the brain, that is brain, spinal cord and
intracranial sections of cranial nerves) in people
who are showing symptoms of the disease. The
tissues at the back of the eye (for example, the
retina) also have high levels of abnormal protein.
These are all referred to as high-risk tissues.
5.22 In vCJD, lower but significant levels occur in
lymphoid tissues earlier in the disease process and,
crucially, before any symptoms are apparent. These
are referred to as medium-risk tissues.
5.23 The abnormal protein is heat-stable, exceptionally
resistant to enzymatic digestion and, once dried
onto instrument surfaces, very difficult to remove
or inactivate by conventional reprocessing.
5.24 This means that special measures are required to
prevent the potential transmission of all forms of
prion disease from one patient to the next as a
result of surgery that employs reusable instruments.
5.25 Patients who have been diagnosed as having a prion
disease who are undergoing surgery present a
possible hazard to other patients. In addition, a
number of people have been categorised as being
at-risk for prion disease by an expert committee
called the CJD Incidents Panel.
5.26 Guidance has been produced by the ACDP-TSE
RM subgroup to help healthcare providers identify
and manage these groups of patients. This guidance
is signposted throughout the CFPP.
5.27 Extra vigilance is required to ensure that
appropriate decontamination measures are in place
when a patient who has been diagnosed as having a
prion disease or who is considered to be at risk
undergoes surgery on high-risk tissues. Extra
vigilance is therefore required for ophthalmic
surgery and intradural operations on the brain.
5.28 The risk of transmission via reusable surgical
instruments is the subject of periodic review.
5.29 The guidance in this framework has been
developed to support acute surgery in the context
of risk control, especially where instruments would
come into contact with high-risk tissues.
Use of instruments on patients at risk
of infection from prion diseases
5.30 Patients who have, probably have, or are at risk of
infection from prion diseases (for example, sCJD
and vCJD) need to be identified before any surgical
procedures are undertaken. For such patients,
precautions will need to be considered. Guidance
from ACDP-TSE RM and the CJD Incidents
Panel should be followed (see links in the
References section).
18
5.31 Key points to note are:
Guidance should be in place locally to ensure
that precautions are taken when dealing with
such patients.
The traceability system for equipment used on
such patients is very important. Also, its
subsequent storage or use must be recorded and
the advice of the CJD Incidents Panel should be
obtained.
Surgical instruments used on high-risk or
medium-risk tissue in an infected patient,
designated infected patient or patient designated
at increased risk of CJD/vCJD should be
retained for use on that same patient after
conventional decontamination as defined in this
framework, or destroyed by incineration.
Depending on the patients risk factors, and the
type of procedure to be carried out, it may be
necessary to quarantine the equipment pending
further investigation.
Some reusable items may need to be disposed of
as they cannot be cleaned to the required
standard. Advice should be sought from the
Microbiologist (Decontamination).
Summary for commissioners and
regulators
5.32 Commissioners should establish whether the local
policies in use by care providers involving surgical
instruments draw clear attention to the need for
risk control with regard to potential exposure of
instruments to the vCJD infectious agent.
5.33 Regulators should pay particular regard to this area
of risk control when examining management
structures, operational processes, the content and
maintenance of records and material indicative of
prion risk control outcomes.
5.34 Care providers and instrument management/
decontamination groups should prioritise attention
to vCJD risk control on a cohesive basis, backed by
local policies and procedures that have been agreed
with commissioners of care.
5.35 Guidance from the ACDP-TSE RM subgroup is
available from their website.
Policy requirements for high prion
transmission risk surgical instruments
5.36 In surgery to the central nervous system (intradural
operations on the brain) and to the posterior eye,
there is a comparatively high risk of prion
transmission from the possible exposure of the
instruments to the prion infectious agents
including, but not limited to, vCJD.
5.37 DH policy is that the measures defined in NICE
IPG 196 (2006) be incorporated into practice and
supplemented by guidance derived from the
ACDP-TSE RM subgroup.
5.38 The risk analysis associated with this
implementation leads to the adoption of the Best
Practice choices within this framework by centres
providing relevant specialist surgical services, and
should be acknowledged by commissioners in the
purchase of care. The agreed approach should be
recorded in a written local policy.
Assessing risk in surgical procedures
5.39 The levels of risk of CJD and vCJD transmission in
surgical procedures are summarised below for the
sake of clarity. These risks apply both to patients
with clinical signs and symptoms of CJD and
vCJD, and asymptomatic individuals who have
been identified as being at increased risk of CJD
and vCJD.
5.40 High-risk procedures: Procedures considered to
be at high risk of transmission of all forms of CJD
involve tissues with high levels of infectivity. These
high infectivity tissues are those found in the
central nervous system, spinal cord and the
posterior eye. High-risk procedures include
intradural neurosurgical operations (involving the
brain, spinal cord and intracranial sections of
cranial nerves), neuroendoscopy, and operations on
the posterior eye (involving the retina or optic
nerve).
5.41 Medium-risk procedures are those involving
olfactory epithelium and spinal ganglia in patients
with all forms of CJD. All procedures involving
tonsils, spleen, lymph nodes, gastrointestinal
lymphoid tissues (for example Peyers patches),
thymus and the adrenal gland in patients with
vCJD are considered to be medium risk.
5.42 Low-risk procedures are those other than the
high- and medium-risk procedures.
5.43 A full list of tissue infectivity is available from Part
4 of ACDP-TSE RMs guidance Infection
control of CJD, vCJD and other human prion
diseases in healthcare and community settings. The
website of the CJD Incidents panel has further
information on the classification of surgical
5 The evidence base: the risk from prion diseases and ndings from the National Decontamination Su
19
procures into high, medium and low risk
procedures.
5.44 A full list of surgical procedures considered high-
risk is given in NICE IPG 196 (2006) guidance.
5.45 A full list of ophthalmological surgical procedures
designated high and low risk is given in ACDP-
TSE RMs Annex L Managing CJD/vCJD risk
in ophthalmology.
Note
The assessment of whether an individual about to
undergo a surgical procedure has, or is at increased risk
of, CJD or vCJD should be done on an individual
patient basis and responsibility for this lies with the
clinical team. Guidance on the assessment to be carried
out before surgery to identify patients with, or at
increased risk of, CJD or vCJD, is available from
ACDP-TSE RMs Annex J Assessment to be carried
out before surgery and/or endoscopy to identify
patients with, or at increased risk of, CJD or vCJD.

Findings from the National
Decontamination Survey
5.46 The core purpose of the NDS was to determine the
progress made by selected healthcare providers and
decontamination service providers in
implementing:
NICE IPG 196 (2006) prion transmission risk
reduction guidance; and
ACDP-TSE RM guidance on specific risk
control for patients at risk of CJD and vCJD.
5.47 In addition, the survey aimed to assess compliance
with decontamination quality systems.
5.48 A site-visit based approach was used in both
departments of surgery and their associated central
sterilization services carried out by the Health
Protection Agency, independent decontamination
engineers and the acute trusts/service providers.
5.49 The survey comprised 30 centres offering
neurosurgical and/or posterior ophthalmic services
within both NHS and private institutions. The
tissues involved in such surgery are high risk for
prion disease and could lead to contamination of
instrument such that they act as vectors of the
infection to subsequent patients. The survey does
not offer an overview of general surgical instrument
decontamination.
5.50 The survey was carried out to inform risk estimates
related to any further spread of human prions via
surgical instruments. The survey findings were
analysed using a figure-of-merit method, which is
designed to emphasise progress and highlight risk-
related omissions. The strategy used for
interpretation of the data was developed with
advice from the Engineering and Science Advisory
Committee (ESAC), the ACDP-TSE Working
Group.
Findings
5.51 The findings demonstrate that the great majority of
centres are successfully implementing surgical
instrument reprocessing quality system guidance,
and that engagement with the guidance is likely to
generate a positive impact on protein removal and
prion infectivity reduction though this is yet to be
demonstrated directly. However, the evidence also
suggests that certain aspects of decontamination
guidance are better followed than others, and that
further development is needed to raise standards
across all of the relevant areas.
5.52 The survey identified that NICE IPG 196 (2006)
guidance had not been implemented fully.
Migration of instruments between sets still occurs.
Single instruments used to supplement sets of
instruments are still used. Technologies that enable
single instruments to be tracked, audited, retained
in their sets and traced to use on individual patients
are only implemented in a small number of centres.
The introduction of a separate pool of instruments
for use on high risk tissues for patients born after 1
January 1997 (a lower prion risk group) has been
implemented only on a limited basis in a very few
centres. The guidance from ACDP-TSE RM on
surgical infection transmission risk control for at-
risk patients was found to be well implemented.
5.53 The survey found that most staff were trained to an
acceptable level in terms of the operation of the
equipment they use, but that there is scope for
broader training and professional development.
5.54 Single-use instruments are not common. However,
reusable flexible neuroendoscopes are substantially
replaced by single-use rigid endoscopes, reducing
the risk in line with NICE guidelines.
5.55 The findings from this survey have been used to
inform this CFPP.
20
Introduction
6.1 Evidence from the NDS identifies that certain
aspects of decontamination guidance are better
followed than others, and that further development
is needed to raise standards across all of the relevant
areas.
6.2 This chapter aims to provide further guidance on
the management of surgical instruments to support
further risk reduction and improvements to patient
outcomes.
6.3 Management of surgical instruments in CFPP
01-01 relates to those used in acute care. In this
context, management of surgical instruments
should make sure that risks associated with surgical
procedures are minimised.
6.4 The following management choices have been
piloted in response to issues highlighted by the
NDS:
keeping instruments moist;
separation of instruments used on high risk
tissues for patients born before and after 1
January 1997;
instrument audit and tracking.
6.5 Other management choices covered in this
guidance include:
loan sets;
loan sets used in high-risk surgical procedures;
repairs;
instrument audit and tracking policy;
single-use instrument tracking and records;
decontamination of surgical instruments that
have been dropped perioperatively.
6.6 See Chapter 4, Regulatory framework and
Appendix B, The National Decontamination
Survey report.
Keeping instruments moist between use
and reprocessing
6.7 Prions are hydrophobic proteins. The attachment
of hydrophobic proteins to surfaces becomes less
reversible if they are allowed to dry fully onto a
surface. Keeping the environment around soiled
instruments at or near saturation humidities
(moist) prevents full attachment of hydrophobic
proteins such that they are more efficiently
removed by cleaning.
6.8 A number of means are available to generate moist
conditions, including the use of enclosed
containers/bagged trays used with single-use moist
pads, gels, foams, water sprays or other methods as
determined locally.
6.9 However, whatever method is used, care should be
taken to ensure that all parts or surfaces of the
surgical instruments are constantly exposed to the
moist environment.
6.10 See Appendix A paragraph A2, Keeping
instruments moist and protein quantification using
OPA/NAC fluorescence.
Separation of instruments used on high
risk tissues for patients born before and
after 1 January 1997
6.11 It is thought that people born since 1 January 1997
have had lower exposure to prions via the food
chain or blood transfusion. These people form a
group at lower risk of prion diseases and thus at a
lower risk of contaminating surgical instruments
with prions. The NICE IPG 196 (2006) risk-
reduction strategy requires that separate pools of
instruments be used for high-risk tissue surgery,
dependent on the patients birth date. This
differentiates between patients who were either
born before 1 January 1997, or who were born on
or after 1 January 1997, and requires that separate
pools of instruments be used for each stream.
6 Management of surgical instruments
21
6.12 If patients born on or after 1 January 1997 had
high-risk surgery before the NICE guidance was
implemented, subsequent high risk-tissue surgery
shall be with instruments in the pre-1 January 1997
pool. For patients born after 1 January 1997 who
have had previous high-risk tissue surgery using
non-NICE IPG 196 (2006) controlled
instruments, NICE IPG 196 (2006) recommends
that any subsequent surgical procedures on these
patients should be carried out using loan sets
normally used for patients born before 1 January
1997. Figure 5 illustrates the pathway for
associating patients with separate instrument pools.
A method of ensuring that sets are used on the
correct patient groups is clearly needed and should
be such as to permit audit to confirm successful.

Figure 5 Instrument pool identification for high-risk tissue surgery
6.13 See Appendix A, paragraph A2, Keeping
instruments moist and protein quantification using
OPA/NAC fluorescence, paragraph A45, Revision
of instrument set: design and management and
paragraph A65, Single-instrument tracking and
management using a commercial decontamination
service provider.
Loan sets
6.14 For certain specialist procedures, there may be a
need for instrument sets that it would be
uneconomic for the provider to purchase and
maintain. These will be supplied from an external
source, used for that procedure only and returned.
These are known as loan sets. This practice
increases the risks associated with the
decontamination and reprocessing of such
instruments, because the organisation may not be
familiar with them. Organisations have also
expressed concern over the decontamination status
of such instruments and the lack of track and
traceability, including potential for instrument
migration. It is a requirement of the Code of
Practice that reusable medical devices should be
decontaminated in accordance with manufacturers
instructions. Therefore, loan sets should be
provided with decontamination instructions so that
staff can ensure their compatibility with local
decontamination processes. Set integrity needs to
be maintained to minimise instrument migration
and enable traceability to the patient. This extends
to the control of individual instruments within
loaned sets, to audit their removal and replacement.
Loan sets used in high-risk surgical
procedures
6.15 Particularly for high risk surgical procedures (see
paragraph 5.39, Assessing risk in surgical
procedures), healthcare providers using loan sets
should ensure that records of such sets are
maintained within their control. These records
should be available for independent review and
should, at a minimum, make it possible to ascertain
the details of the instruments contained within the
set and the surgical units within which the set has
been used. Dates and session times for each use
should also be recorded. The identity of patients
with whom the sets have been used should be
traceable from the record but, for patient
confidentiality, maintained within the secure
environment of the clinical service providers
concerned.
6.16 Instruments within loan sets shall be subject to
quality system and control measures at least equal
to those normally applied in the surgical centres
where they are used. This applies equally when
surgeons or other team members are the sponsor of
any loan arrangement.
6.17 Theatre staff and SSDs should take special care to
ensure integrity of loan sets and, for instruments
used on high risk tissues, their membership of pre
or post 1 January 1997 instrument groups from
receipt to dispatch.
Repairs
6.18 Any instrument used on high risk tissues that are
removed for repair should be returned to the
instrument set from which it was removed.
22
Instrument audit and tracking
6.19 There is a need to track and trace reusable surgical
instruments throughout their use and reprocessing.
This is to avoid instrument migration and is an
essential requirement of the MDR and the Code of
Practice.
6.20 Records should be maintained for all the
instrument sets (and supplementaries for high-risk
procedures) identifying:
the cleaning and sterilization method used
a record of the decontamination equipment and
cycle
the identity of the person(s) undertaking
decontamination at each stage of the cycle
the patients on whom they have been used and
details of the procedures involved.
6.21 This information is required so that instrument sets
(and supplementaries for high-risk procedures) and
the patients they have been used on can be traced
and the instrument sets and supplementaries
recalled when necessary.
6.22 The NDS shows that the use of single-instrument
tracking and associated audit techniques remains
under-used within hospitals in England. The
maintenance and quality control of instruments
was also shown to be poorly managed by the NDS
survey information.
6.23 The reunification of instruments with their sets
following repair or replacement benefits from
accurate instrument identification. Tracking is
likely to mitigate other factors, including those
associated with operative failure due to the absence
of key instruments or arising from poor adherence
to scheduled instrument maintenance particularly
those which have electrical components.
6.24 For those instruments, including delicate
components such as electronic devices or imaging
related markers, the use of single instrument
identification may be of special value. When
marking is combined with properly managed
decontamination procedures the individual
instrument may be correctly identified as requiring
a non-standard approach to washing, disinfection
or sterilization.
6.25 Individual instruments may have warranties
associated with them which carry a guarantee.
However if the individual warranted instrument
cannot be reliably identified to a standard which is
satisfactory to the supplier, then it is unlikely that
the warranty can be evoked. A similar argument
applies to instruments such as arthroscopy scissors,
which are limited in terms of the number of use
cycles, authorised by the manufacturer under CE
marking.
6.26 NICE IPG 196 (2006) guidance requires that high-
risk tissue instrument sets used with patients born
since 1 January 1997 form a pool within which
instruments must be retained and from which
other instruments must be excluded. This is
challenging when supplementary instruments are
used. Teams are likely to find effective streaming of
non-marked instruments difficult. The use of larger
sets which include supplementary instruments will
partly mitigate this risk, particularly when
combined with instrument marking, tracking and
audit techniques.
6.27 See Appendix A paragraph A45, Revision of
instrument set: design and management and
Appendix B: The National Decontamination
Survey report.
Single-use instrument tracking and
records
6.28 When single-use surgical instruments are used, they
must be separated from reusable surgical
instruments and disposed of at the end of the
procedure. It is important that the single-use
instruments are not allowed to enter reusable
instrument sets.
Decontamination of surgical
instruments that have been dropped
perioperatively
6.29 Instruments dropped or which otherwise have their
sterility compromised during use should be
replaced. There should, where standard sets are
being used, always be at least one readily accessible
spare set so this can happen with minimal delay.
The local policy to ensure this occurs efficiently
should be established with the theatre users, the
theatre manager and the DIPC (or their nominee).
This may on rare occasions not be possible, for
example if use of loan sets does not allow this.
6.30 On these occasions, a local risk assessment by the
operating team should assess the relative risks of the
options available, for example: the continuation of
the procedure without that item; the abandonment
23
of surgery; the return of that item to the SSD for
full decontamination.
6.31 Current DH policy remains to reduce
inappropriate local reprocessing such as the use of
non-compliant, non-validated bench top sterilizers.
Development of local policies and procedures needs
to consider benefits, risk and cost of the options
available.
6.32 Where benchtop sterilizers are used these should be
a last resort, and instruments should be subject to
local manual cleaning to an agreed procedure. The
unwrapped item should be processed in a
downward displacement steam sterilizer maintained
and validated including undertaking the necessary
daily automatic control tests
6.33 There should be measures in place to audit each use
of this sterilizer and identify which cycles are for
the sterilizers routine validation and which are for
surgical instrument decontamination. This audit
should ensure that the sterilizer is only used for
instrument decontamination in the exceptional
circumstances outlined above. It should be
appreciated that this should be a last resort and
should be reported through the hospitals adverse
incident report system.
Staffing roles and responsibilities
6.34 Staff undertaking decontamination and
management of decontamination should be able to
demonstrate their competencies and training in this
area through:
6.35 Individual training records, detailing the
appropriate core competencies and any other
supplementary training, should be updated at least
annually. Line or training managers should be
responsible for maintaining these records.
6.36 The approach adopted in this CFPP is to identify
the distinct functions that need to be exercised and
the responsibilities that go with them. The titles
given are therefore generic; they describe the
individuals role in connection with
decontamination but are not intended to be
prescriptive job titles for terms of employment.
Indeed, many of the personnel referred to may not
be resident staff but employed by outside bodies
and working on contract. Some of them will have
other responsibilities unconnected with
decontamination and in some cases the same
individual may take on more than one role.
6.37 Whatever model of operational management is
chosen, the roles and responsibilities of the
individuals involved should be clearly defined and
documented. In every case, however, it should be
possible to identify a User who is responsible for
the day-to-day management of the
decontamination of reusable surgical instruments.
The philosophy of this CFPP is to invest the User
with the responsibility for seeing that the
decontamination process is operated safely and
efficiently.
6.38 The following personnel are referred to in this
CFPP.
Management definition
6.39 Management of a healthcare organisation
performing decontamination is defined as the
owner, chief executive or other person of similar
authority who is ultimately accountable for the safe
operation of the premises, including
decontamination.
Executive Manager (for example, chief
executive);
Decontamination Lead (this person may also act
as the Designated Person if locally agreed);
Designated Person
Surgical Instruments Manager
Senior Operational Manager (for example,
estates manager);
User (for example, sterile services manager);
Authorising Engineer (Decontamination);
Authorised Person (Decontamination);
Competent Person (Decontamination);
Director of Infection Prevention and Control
(in England);
Infection Control Doctor;
Microbiologist (Decontamination);
Operator;
Manufacturer;
Contractor;
Purchaser;
Competent Person (Pressure Systems).
24
Executive Manager
6.40 The Executive Manager is defined as the person
with ultimate management responsibility, including
allocation of resources and the appointment of
personnel, for the organisation in which the
decontamination equipment is installed.
6.41 Depending on the nature of the organisation, this
role may be filled by the general manager, chief
executive or other person of similar authority.
Decontamination Lead
6.42 Every healthcare organisation should have a
nominated Decontamination Lead with
responsibility for decontamination, either at board
level or who has line management responsibility to
a senior responsible person at that level.
6.43 The Decontamination Lead should report directly
to the Executive Manager.
6.44 The Decontamination Lead is organisationally
responsible for the effective, and technically
compliant, provision of decontamination services.
6.45 The Decontamination Lead is responsible for the
implementation of an operational policy for
decontamination. He/she should ensure that the
operational policy clearly defines the roles and
responsibilities of all personnel who may be
involved in the use, installation and maintenance of
decontamination equipment. The
Decontamination Lead is also responsible for
monitoring the implementation of the policy.
6.46 The Decontamination Lead may delegate specific
responsibilities to key personnel; the extent of such
delegation should be clearly set out in the
operational policy together with the arrangements
for liaison and monitoring.
6.47 The Decontamination Lead may also act as the
Designated Person.
Designated Person
6.48 This person provides the essential senior
management link between the organisation and
professional support.
6.49 The Designated Person should also provide an
informed position at board level.
6.50 The Designated Person should work closely with
the Senior Operational Manager to ensure that
provision is made to adequately support the
decontamination system.
Surgical Instrument Manager/coordinator
6.51 The manager of surgical instruments (medical
devices) is designated as the person assuming
responsibility for coordinating activity between the
theatre, decontamination and supply / purchase
teams. The person fulfilling that role should also
ensure that the inventory of surgical instruments is
proactively reviewed and managed in accordance
with this guidance, clinical requirements and
industry best practice.
6.52 Specifically, this officer will:
make judgements on the suitability of reusable
instruments in consultation with surgical teams
and those responsible for decontamination. This
work will be assisted by the formation of a
working group for ongoing collaboration;
determine appropriate instrument-set structures
designed to assist in the prevention of leakage of
instruments between sets (including preventing
the movement of supplementary instruments
between sets) in consultation with clinical
specialists and decontamination teams;
ensure that guidance on tracking and
traceability is appropriately applied to all
instruments (this includes loan sets) and
collaborate with those responsible for patient
records to ensure any patient with whom they
are used can be identified and linked to the sets
or individual instruments used;
ensure that missing or damaged surgical
instruments are replaced preserving the
appropriate set structure;
oversee the monitoring of condition and
suitability for surgical instruments;
oversee the audit process for instrument sets
from procurement through use,
decontamination and final disposal;
ensure instrument sets never used are reviewed
and/or disposed of;
oversee actions to provide a mechanism for
routinely revalidating instrument-set content
(for example, annual sign off of the tray
checklist by surgical teams);
ensure the leakage of surgical instruments
between sets is minimized by effective process
mapping using recommended audit procedures,
post-operative checks, the signing of tray
checklists by theatre sister, and decontamination
25
facility processing techniques (that is, specific
instrument set contents are kept together
throughout the decontamination cycle);
ensure instrument sets with observed missing or
damaged content are updated through targeted
investment ensure the healthcare organisation
has documented policies in place for the
operational management of its instrument-set
inventory; these should include policies on (as a
minimum);
manage the loaning of instrument sets to and
from external suppliers using the audit
techniques given in this guidance;
purchase new instrument and sets (including, as
a minimum, the documented approval of the
theatre team, decontamination specialists and
Control of Infection lead);
ensure repaired instruments are returned to the
original instrument set;
oversee a standardised approach to instrument
nomenclature throughout the healthcare
organisation;
ensure all Instrument sets have an accurate
version-controlled checklist validated by the
surgical team (preferably in an electronic
format);
determine that all Instrument stores (including
wards and departments) are audited on a regular
basis, and all redundant items removed from
circulation;
ensure a mechanism is in place for addressing
instrument set usage non-conformities such as
wet packs, torn tray wrap etc.;
provide and oversee mechanisms to ensure all
instruments in the healthcare organisations
inventory are fit for purpose (for example
regular review of appropriate records);
ensure the healthcare organisation holds an
accurate database of its instrument-set inventory
including tray type, location of use and stock
level;
ensure all instruments sets which are critical in
stock levels are risk assessed, to maximize
patient safety and inform instrument set
investment.
Senior Operational Manager
6.53 The Senior Operational Manager is technically,
professionally and managerially responsible (and
accountable to the Decontamination Lead) for the
engineering aspects of decontamination (for
example, decontamination equipment and the
environment).
User
6.54 The User is defined as the person designated by
Management to be responsible for the management
of the process. The User is also responsible for the
Operators.
6.55 In the acute sector, the User could be a sterile
services manager.
6.56 The principal responsibilities of the User are as
follows:
to certify that the decontamination equipment
is fit for use;
to hold all documentation relating to the
decontamination equipment, including the
names of other key personnel;
to ensure that decontamination equipment is
subject to periodic testing and maintenance;
to appoint operators where required and ensure
that they are adequately trained;
to maintain production records;
to establish procedures for product release in
line with the quality management system;
to ensure that procedures for production,
quality control and safe working are
documented and adhered to in the light of
statutory requirements and accepted best
practice.
6.57 The User may seek the advice of infection control
teams, which may consist of a DIPC, Infection
Control Doctor or Microbiologist
(Decontamination).
Authorising Engineer (Decontamination) (AE(D))
6.58 The role of the AE(D) should be fully independent
of the healthcare facilities structure for
maintenance, testing and management of the
decontamination equipment.
6.59 The AE(D) is defined as a person designated by
Management to provide independent auditing and
technical advice on decontamination procedures,
26
washer-disinfectors, sterilizers and sterilization and
to review and witness documentation on validation.
6.60 The AE(D) is required to liaise closely with other
professionals in various disciplines and,
consequently, the appointment should be made
known in writing to all interested parties.
6.61 The AE(D) should assist healthcare organisations
in the appointments and interviews of the AP(D)s
and their consequent annual assessments.
The AE(D) should have a reporting route to the
Decontamination Lead and should provide
professional and technical advice to the AP(D)s,
CP(D)s, Users and other key personnel involved
in the control of decontamination processes in
all healthcare facilities.
Responsibilities
6.62 The principal responsibilities of the AE(D) are as
follows:
to provide to Management and others, general
and impartial advice on all matters concerned
with decontamination;
to advise Management and others on
programmes of validation and testing;
to audit reports on validation, revalidation and
yearly tests submitted by the AP(D);
programmes of periodic tests and periodic
maintenance;
operational procedures for routine production;
to advise Management on the appointment of
the AP(D);
to provide technical advice on purchasing and
selection of decontamination equipment for the
users;
to provide technical advice on the relevant
guidance on decontamination equipment and
procedures.
6.63 Each appointed AE(D) is independent in the
advice and roles of the decontamination procedures
and responsibilities for the effective management of
the guidance and safety as recommended by the
DH and regional administrations of Scotland,
Wales and Northern Ireland.
The Institute of Healthcare Engineering and Estate
Management (IHEEM) supports and operates the
DTP (Decontamination Technology Platform) which
is made up of IHEEM-registered AE(D)S (see link in
the References section).
Authorised Person (Decontamination) (AP(D))
6.64 See Responsibilities in CFPP 01-01 Part B.
Competent Person (Decontamination) (CP(D))
Director of Infection Prevention and Control
(DIPC)
6.66 The DIPC in England is defined as the person
responsible for the infection control aspects of
decontamination. The designated person is
accountable directly to the Chief Executive and to
the Board. If the person has a degree or equivalent
qualification in microbiology, he/she may also
fulfill the role of the Microbiologist
(Decontamination).
Infection Control Doctor
6.67 The Infection Control Doctor is defined as a
person designated by Management to be
responsible for advising the User on all infection
control aspects.
Microbiologist (Decontamination)
6.68 The Microbiologist (Decontamination) is
designated by Management to be responsible for
advising the User and that Management on
microbiological and infection prevention aspects of
the decontamination of reusable surgical
instruments.
6.69 The Microbiologist (Decontamination) should
have a relevant degree or equivalent qualification
(for example, microbiology or medicine) together
with relevant experience. In some organisations, the
Microbiologist (Decontamination) and Infection
Control Doctor may be the same person.
Operator
6.70 The Operator is defined as any person with the
authority to operate decontamination equipment,
including the noting of instrument readings and
simple housekeeping duties.
27
6.71 Operators should have their tasks defined in their
job description. Operators should also have
documented training records to demonstrate that
they are competent at undertaking their assigned
tasks.
Manufacturer
Contractor
Purchaser
Competent Person (Pressure Systems)
6.75 The Competent Person as defined in the Pressure
Systems Safety Regulations 2000 is not the same
person as the Competent Person
(Decontamination) defined in this CFPP. The
former is a chartered engineer responsible for
drawing up a written scheme of examination for
the system. The latter is the person who carries out
maintenance, validation and periodic testing of
washer-disinfectors and sterilizers.
6.76 Most insurance companies maintain a technical
division able to advise on appointing a CP(PS).
The AE(D) should also be able to provide advice.
28
7.1 A range of technologies that may be valuable in the
inactivation of prions is becoming available. These
technologies include: the use of proteolytic
enzymes; strong alkaline solutions including
sodium hydroxide; instrument exposure to cold
plasmas; and high chemical activity gas or vapour
agents such as ozone or activated hydrogen
peroxide.
7.2 The issues surrounding efficacy and validation in
regard to prion inactivation as a part of
decontamination of surgical instruments are
complex. Essentially, animal assays involving the
exposure of rodent models to contaminated wires
which have been subject to decontamination
processes using the new technologies are key. These
assays are in many cases very competently
conducted and utilise well-designed methods
incorporating vigorous controls. However, the
range over which these assays permit measurements
is restricted when compared to the potential scope
of prion activity present as a contaminant.
7.3 A review of the approach to evaluating prion
inactivation technologies can be found in the
Engineering & Science Advisory Committee into
the Decontamination of Surgical Instruments
Including Prion Removal (ESAC-Pr) New
Technologies Working Group Report on Prion
Inactivating Agents (2008).
7 Inactivation of prions using novel
technologies
29
Note
The views expressed in this Appendix are those of the
editors and pilot study representative and not
necessarily those of DH.

A1 The following DH-funded pilot studies have been
active in addressing a number of key risk-reduction
alternatives:
quantification using OPA/ NAC fluorescence
(a collaboration between GOSH, UCLH and
Queen Mary University of London)
Revision of instrument set design and
management (undertaken at Newcastle upon
Tyne Teaching Hospitals NHS Trust)
Single instrument tracking using an external
commercial decontamination services provider
(the Birmingham Childrens Hospital NHS
Trust in collaboration with its decontamination
services provider)
Protein quantification using epifluorescence
scanning (University of Edinburgh/Royal
Infirmary of Edinburgh)
Protein quantification using EDIC/
epifluorescence microscopy (University of
Southampton)
Keeping instruments moist and
protein quantification using OPA/NAC
fluorescence
A2 Centres involved: GOSH/UCHL/Barts & Queen
Mary University of London joint pilot studies.
Aims and objectives
A3 These multi-factorial linked studies, focused on
prion risk reduction, set out to:
track instrument sets and single instruments to
support the implementation of NICE IPG 196
(2006) guidance;
trial aspects of NICE IPG 196 concerned with
the protection of patients born after 1 January
1997. This specifically includes the purchase of
new instrument sets (GOSH) for high risk
neurosurgical procedures, but not posterior
ophthalmic, applications;
maintain contaminated instruments in a moist
environment after use in for all neurosurgery
procedures before reprocessing;
develop protocols for the use of a novel
enhanced protein detection and quantification
technology for assessment of neurosurgical
instrument contamination after washing and
disinfection.
Methods and approaches for each component of
these studies
A4 Each of the objectives had written protocols
developed by the hospitals senior decontamination
staff:
Margaret Hollis (head of decontamination at
GOSH)
Sylvia Martin (decontamination and sterile
services manager at UCHL).
A5 They were assisted by Terry Durack (head nurse,
clinical equipment, products and practice/co-chair
clinical practice committee at GOSH) with support
from the GOSH neurosurgical team, Elaine
Cloutman-Green (clinical scientist at GOSH), and
David Perrett (professor of bioanalytical science at
Queen Mary University of London).
A6 The methodologies for each of the objectives were
as follows:
1. Single-instrument and instrument set tracking
A7 Recommendation 1 of NICE IPG 196 (2006) was
pursued through a combination of set component
Appendix A: Reports from DH pilot studies
concerning the implementation of NICE IPG 196
(2006) guidance
30
rationalisation and marking of instrument sets and
individual instruments using the GS1 scheme in
conjunction with commercial optical barcode
technology. The instrument sets were initially
rationalised, and records of supplementary
instrument use established. However, the radical
redesign of sets reported in the Newcastle pilot
study did not form part of the protocol here.
Single-instrument tracking started in the inspection
area where clean instruments were tracked before
wrapping. Each instruments data code was scanned
and this was related to the GS1 barcode on the host
tray to assess set integrity and records used for
auditing. Where errors were found, instruments
were repatriated to their intended tray before
packing and sterilization.
A8 The second single-instrument scan took place when
the used instruments were returned to the SSD.
Where necessary instruments were subject to
preliminary cleaning and then scanned.
Instruments that had migrated to a different set
were detected at this point and repatriated to their
original sets in the washroom.
A9 Single-instrument tracking was not applied in the
operating theatre suite; however, each tray (and
therefore set) was logged in and out of theatre at
the point of collection. Information was gathered
using GS1 barcode technology.
A10 Instrument tracing to the patient was also achieved
via the GS1 codes but was implemented only at set
level, under the presumption that the instruments
had been used as a coherent set in a patient
procedure. The system was subject to appropriate
security in terms of patient identity and permitted
rapid tracing a marked change from the situation
prior to the introduction of such tracking and
tracing.
A11 While the single-instrument tracking pilot study
was restricted to neurosurgery, track-and-trace at
the set level was used across a broad range of
surgical procedures in both centres concerned.
A12 Comparative control was provided by one of the
partners within the pilot adopting each new facet
whilst the other did not. Once a pilot exercise is
concluded, the benefits are shared across both
centres and applied as appropriate.
2. New instrument sets for patients born after
1 January 1997
A13 The aspects of the pilot study concerned with
procurement, quality control and use of new
instrument sets for patients born after 1 January
1997 were taken forward after the single-
instrument tracking methods were in place;
otherwise migration between sets could have
prejudiced any risk reduction.
A14 A review of instrument tray content was conducted
in consultation with the surgical teams, led by the
appropriate paediatric neurosurgeons. This
produced modest revisions to the set contents,
primarily aimed at ensuring that the clinical needs
were covered by the available instruments, with
minimal or no requirement for the use of
instruments supplementary to those sets. However,
the radical change in set design and use of much
larger sets in groups observed in the Newcastle pilot
study was not adopted at GOSH or UCLH.
A15 The new instrument sets were marked with the
appropriate GS1 codes by the use of a 2D matrix
technology to allow individual instrument
identification. Each instrument code was registered
to the tracking system, verified and then matched
to the parent sets, but no grouping of the sets was
used.
A16 The integrity of instruments within their work
stream was tested by a number of dummy use/
reprocessing cycles in which they were subject to
tray and instrument level tracking. The results from
these cycles were evaluated, with particular
attention to set integrity and other aspects of
patient safety, such as ensuring that the marking
process had not compromised the instruments.
A17 The instruments were tracked at the point of
receipt into the SSD and again prior to inspection
before packing. Audit record-keeping files were
ascribed to each set and the tracing system linked
to patient age.
A18 NICE IPG 196 (2006) guidance and local policies
applied within the pilot work call for additional
restrictions on the use of these instruments. These
restrictions exclude patients who have previously
been operated on using non-age-restricted sets. In
addition, the segregated instruments are not to be
used on patients identified as being at risk, as
defined by ACDP-TSE RM. Lastly, the
instruments are not to be used on patients coming
from overseas for treatment unless surgical and
Appendix A: Reports from DH pilot studies concerning the implementation of NICE IPG 196 (2006) guida
31
other prion infection transmission risk factors can
be demonstrated to be low as defined by ACDP-
TSE risk definitions.
3. Keeping instruments moist between use and
reprocessing
A19 The use of an environment designed to keep
instruments moist after use and prior to
reprocessing has been developed and evaluated
using a single semi-commercial methodology.
Although the pilot was restricted only to
neurosurgery, staff reported that adapting the
protocols for other surgical areas is achievable.
A20 The instruments are managed during use in a
conventional way and no attempt is made to keep
instruments artificially moist during the
neurosurgical procedures; observation suggests that
the instruments do not appear to dry out fully after
use, except in the most prolonged surgical
undertakings.
A21 After use, strategies to maintain the instruments in
a moist atmosphere or environment were
implemented: briefly, the instruments in their trays
were inserted into a purpose-designed polythene
bag and sprayed using a commercial product
containing water, gel agents and a bacteriostat. The
bag was then sealed with a commercial tie and
removed from the theatres dirty utility room in the
usual way.
A21 The instrument trays remained in their bags until
SSD staff were ready to commence the post-use
checks and instrument tracking procedures. As the
centres in this pilot used on-site reprocessing, the
period between completion of a surgical procedure
and the inspection in SSD was as short as one hour.
However, for operational reasons, storage overnight
or even over a weekend may be required.
A22 The two-centre control strategy in which one
centre remained unchanged and the other pursued
the developmental protocols proved particularly
useful. Specifically, comparisons were made
between protein contamination of instruments kept
in a moist environment post-use against similar
instruments in which moist conditions were not
applied.
4. Protein detection and quantification technology
A23 In conjunction with GOSH and UCLH, the
sensitivity of the ninhydrin and biuret tests (see
Periodic tests in CFPP 01-01 Part D) for residual
protein on instruments was evaluated under both
laboratory and SSD conditions. The studies used
residual protein measurements on both washed and
visually contaminated stainless steel tags and
performed by SSD personnel. The findings
confirmed earlier results that both methods are
comparatively insensitive at the detection of
residual proteins on stainless steel.
A24 A new protein detection and quantification
technology has been developed by Queen Mary
University of London using OPA/NAC chemicals
and a specifically binding isoindole fluorescent
label. This involved spraying the instruments,
allowing air-drying, and then viewing the
fluorescence distribution on the instrument using a
box (G-box) containing a light source, filters and
a digital imaging system. The digital image output
was mapped to a matrix display, and quantification
software was used to generate greyscale or false-
colour values to represent the strength of the
fluorescent signal. Both the reagent and detection
methods have been patented.
A25 Continuing uncertainties over toxicology related to
the OPA/NAC chemicals and to the derivatives
formed when bound to the detected proteins give
rise to a need for caution at present. Whilst the
existing evidence suggests there is very little risk to
staff taking normal precautions when using the
reagent or to patients from residuals on
instruments, the work has nevertheless been
conducted in parallel with the neurosurgical
instrument stream rather than being applied to the
instruments themselves. Tags (316-grade stainless
steel) were used with a test soil prepared from
rodent brain in order to simulate neurosurgical use
and develop the approaches necessary to use the
new system in an SSD. In addition, single-use
neurosurgical instruments were also used in the
pilot study.
A26 If an evaluation of toxicological acceptability is
satisfactory, this methodology will be redeveloped
for direct application to naturally contaminated
instruments in use in paediatric neurosurgery.
1. Single-instrument and instrument set tracking
A27 Practical work on the pilot commenced with the
installation and trial of instrument tracking systems
in the SSD only. A single-instrument and tray-
tracking methodology was developed, together with
32
a related audit procedure and controlled methods
for repatriation of single instruments in the event
of movement between or loss from sets. The pilot
was then extended to include the installation of
tracking equipment in the theatre, though this is
restricted to instrument trays (and sets by
inference). Conventional instrument accounting
procedures are used to ensure patient safety and to
confirm that all instruments are returned to the
trays after use.
A28 The single-instrument tracking strategy used in the
SSD was related to audit and record-keeping. The
initial steps were carried out in the instrument
assembly and packing (IAP) room and linked each
individual instrument to the relevant tray. An alert
system has been developed which indicates the
absence of an instrument (which can have real
importance in terms of the subsequent efficiency of
clinical care), instruments included in the wrong
tray and duplication of instruments within trays.
The system ensured that trays exhibiting such
defects were not released for use in theatre.
A29 Second-stage development covered the protocol
and implementation for single-instrument tracking
upon the return of instruments/trays to the SSD
after use. The protocol required the identification
of each individual instrument and repatriation of
displaced instruments in the washroom as
necessary.
A30 Further work has been conducted to optimise
single-instrument scanning in the IAP room so that
it may be carried out as a single exercise alongside
the visual examination of each individual
instrument.
A31 Patient tracing can only be linked to tray-level
identification. For this, the GS1 coding structure
was used, and the trace information enabled
identification of the patient, with appropriate
security barriers, and permitted the history of the
tray to be seen, together with the names or codes
for each of the operatives conducting the work. The
computer system was developed to give near real-
time operation so that look-back exercises to detect
issues such as surgery to a vCJD at-risk patient are
available as a rapid service, should they be needed.
A32 GOSH is contemplating a move to off-site SSD
services and has accordingly conducted an
evaluation of single-instrument scanning post-
surgery, using space made available in the dirty
utility rooms. To date, this approach works well
and observations suggest that instrument washing
prior to code scanning is unlikely to be routinely
necessary.
2. New instrument sets for patients born after
1 January 1997
A33 The previously mentioned desktop exercise defined
the working rules for this part of the pilot, as
described in Methods and approaches above.
Clinical use of the new instrument sets is now in
progress, governed by strict protocols derived from
the NICE IPG 196 guidance in terms of
determining which patients are selected for the use
of the post 1 January 1997 instrument stream, as
described above. Little or no leakage of instruments
between this second paediatric stream and the body
of paediatric instruments has been observed.
Additionally, the protocols governing instrument
tracking, traceability and the relationship to those
categorised patients work well and permit the
history of instrument use to be accurately plotted.
3. Keeping instruments moist between use and
reprocessing
A34 The advantages of this procedure in terms of aiding
the effectiveness of subsequent decontamination,
particularly in respect of protein contamination
removal, are recorded in (4) below. It is intended
that post-surgery moist instrument environment,
protein quantification and washer-disinfector
optimisation will be considered together for the
remainder of the pilot.
A35 In operational terms, the additional procedures in
theatre were limited to the placing of trays
following normal audit to ensure that all
instruments are present into specially designed
and robust plastic bags. This process was removed
to the dirty utility room where space was allocated
for the purpose. The process was very simple,
involving only the bagging described here, followed
by the use of a spray/ gel and closure of the bag
with a purpose-made tie. Bag failure and/or the loss
of tie have not been observed. The procedure was
conducted by a designated trained member of
theatre staff and adds only some three-to-five
minutes to the normal recovery and removal of
surgical instruments following closure of a
neurosurgical procedure.
A36 For some instruments, exposure to this moist
environment appears to have produced a marginal
increase in the rate of polished surface
deterioration. This effect was variable across
33
instrument sets, with very little surface quality loss
being apparent in the higher grade stainless steel
instruments, whilst some instruments thought to
have been constructed from lower grade steel
exhibited noticeable deterioration.
A37 Teams contemplating the modernisation of
instrument sets as part of a drive towards more
efficient surgery would be well-advised to consider
ensuring that any new instruments purchased have
a high corrosion resistance so as to better support a
move towards the use of moist conditions.
4. Protein detection and quantification technology
A38 In the trials using stainless steel tags, a five-order
reduction in the total mass of residual protein
contamination following processing of moist
instruments through a standard cycle incorporating
the use of a proteolytic enzyme-based detergent was
observed compared to dry instruments processed
without the proteolytic agent. This effect has been
observed over a large number of repetitions of the
pilot exercise, though the contribution made by the
components within the process cannot be resolved.
In addition, if there was a difference caused by the
detergent, it is not known whether it was a
difference in the surfactant component or if it was
due to a proteolytic component of one of the
detergents.
A39 Since the ninhydrin and biuret tests were
confirmed to be relatively insensitive in detection
of proteins on instruments, a much improved
procedure is required. The procedure should be
relatively cheap and easy to use in a SSD
environment but most importantly it should be
sensitive towards protein residues on instruments.
A40 The OPA/NAC fluorescence and digital camera-
based system has proved effective in terms of both
the detection and a degree of quantification of
protein residues on washed and disinfected items.
However, safety issues identified in the pilots
remain unresolved, and so a methodology
employing stainless steel tags contaminated by
rodent brain homogenate was used.
A41 First among the concerns is the toxicology of the
OPA/NAC fluorescent agent. This is being
investigated but until the local ethics group are
satisfied that the materials are non-toxic or do not
make contact with the patient, the envisaged
testing of surgical instruments in actual use cannot
be pursued.
A42 If and when the process is established to be
acceptable, work will move to direct assessment of
contamination levels on instruments kept moist
following neurosurgical applications.
A43 A number of key issues have emerged and are under
current consideration: Current pilot information
suggests that the most appropriate strategy for
protein testing will involve conducting the OPA/
NAC fluorescence examination during inspection
following washing and disinfection. To remove the
chemistries used and any derived products, a
repetition of the washing and disinfection cycle for
the whole set regardless of the test status of
individual instruments contained therein will be
necessary.
A44 See the section on Periodic tests in Chapter 2 of
CFPP 01-01 Part D.
Revision of instrument set: design and
management
A45 Centre involved: Newcastle upon Tyne Teaching
Hospitals NHS Trust.
Aims and objectives
A46 This pilot was established to investigate methods of
reducing the risk of CJD transmission between a
carrier patient and subsequent patients subject to
surgical treatment using the same reprocessed
instruments. This accords with the principles of
NICE IPG 196 (2006).
A47 In practical terms, two requirements were
examined:
a. the prevention of migration of surgical
instruments from one neurosurgical set to
another; and
b. enabling the control of instrument-specific risks
by the use of single-instrument tracking via GS1
unique identifiers and a barcode system.
A48 Neurosurgical and posterior ophthalmic (PO)
procedures were selected as the area for pilot
activity because of the potentially high risk of CJD
transmission via surgery on these tissues.
Method and approach
A49 The jointly agreed methodology between DH, the
Advisory Committee on Decontamination Science
and Technology (ACDST), and Newcastle upon
Tyne Teaching Hospitals NHS Trust was originally
based on the repatriation of instruments to their
34
sets by the use of records and audit. This required
data collection from individually marked
instruments, which during initial trials proved
cumbersome and demonstrated that routine
leakage between sets in both the operating and
decontamination environments ran at potentially
significant levels.
A50 The pilot team took the view that the high levels of
leakage observed and the difficulties in tracking
supplementary instruments warranted fundamental
review of the goals of the pilot; the appropriateness
of the set structures and contents for use in modern
neurosurgery was questioned.
A51 The pilot direction was therefore changed to focus
upon the appropriateness of the neurosurgical sets
used in Newcastle to the range of techniques to
which they are applied.
A52 A specific review of neurosurgical sets for a range of
major interventions was conducted by a team
consisting of decontamination specialists, surgeons,
nurses and theatre technical staff. This showed poor
correlation between the operative procedure design
and the instruments provided to support the
conduct of that procedure, with very high numbers
of supplementary instruments routinely being used
(Table A1). The set structures and contents were
reappraised and new, larger sets (commonly referred
to as big sets) were created. In many cases,
unused instruments were removed from sets, and
frequently used supplementaries were added to the
sets with which they were being used. This process
was typified by the amalgamation of existing
instrument sets (for example craniotomy light
and craniotomy heavy) into one casket/
instrument set group.
Hospital Number of trays Number of
supplementary
instruments
Royal Victoria
Infirmary (RVI)
106,991 150,876
Freeman Hospital
(FH)
73,536 55,254
Newcastle
General Hospital
(NGH)
14,521 34,554
Newcastle Dental
Hospital (NDH)
154,068 167,351
A53 This work led to a smaller number of larger sets
within the neurosurgical area and a very marked
reduction both in the use of supplementary
instruments and in leakage between sets. This is a
product of the reduced probability factors that arise
from the sets being both larger and more
appropriate to their application.
A54 In order to ensure that sets used for procedures
where a high risk of CJD transmission may occur
should a carrier of the disease be encountered (that
is, work on the central nervous system (brain) or
PO structures), a colour-coding system was
introduced. These colour codes differentiate sets
and their associated caskets according to the CJD
transmission risk group into which the associated
surgical procedures fall.
A55 This rationalisation was backed by continued use of
GS1-based set tracking and the selective application
of single-instrument tracking techniques.
A56 In addition to NICE recommendations that
leakage of instruments used for high-risk tissue
surgery should be minimised, NICE has also
recommended that sets used on patients born after
1 January 1997 be kept completely separate from
those used for older patients. As a safeguard,
Newcastle introduced colour-coded lids for these
differently designated sets. The sets for adults and
older children are blue, whilst yellow lids are used
for the younger age group. This simple technique
has proven reliable in practice and imposes very low
operational overheads.
A57 These techniques are complemented by an audit
based on written procedures, carried out both by
technicians in SSDs and in a near-identical way by
those overseeing the use of instruments in the
operating theatres. This step is designed to ensure
that sets remain complete and that any residual
leakage is detected. In addition, the audit process
supports the detection of unsatisfactory
instruments that may compromise surgical quality.
It has also performed well in exposing the absence
of instruments from sets, which may also have
clinical consequences.
A58 The tray tracking system reconciles the trays with
their parents sets and with the casket system, where
employed. At the set level, the unique identifiers
permit tracing to each patient with whom the
instrumentation is used, via a link to the patient
administration systems.
Table A1 Numbers of trays and supplementary instruments used in
four Newcastle hospitals between April 2006 and March
2007
35
A59 The success of the audit technique is critically
dependent on staff training and on the
maintenance of instrument lists so that these keep
pace with both the development of surgical
techniques and the actual inventory present.
A60 The audit and record-keeping approach is
supplemented by the printing of barcoded records,
which are entered into the patients notes. This is a
safeguard against the risk that a failure in
computer-based record-keeping might compromise
the track-and-trace capability of the local service.
A61 The participating Trust has recognised the
following marked benefits:
a. Standards of accountability and audit
performance in terms of supporting surgery
through provision of appropriate quality-
controlled surgical instruments exhibit marked
improvement.
b. The new system is shown to be sufficiently
robust that sets may be tracked throughout the
entire use and decontamination cycle with no
detectable loss of content stability. The tracking
techniques are applied prior to instrument
washing, prior to packing of instruments for
subsequent sterilization and upon unwrapping
in the operating theatre.
c. Audit has shown that the system permits very
reliable linkage between the patient, procedure
and the instruments used within the overall
record.
d. Linking the comprehensive record system to
engineering quality system records and operator
identification gives a comprehensive overview
and supports effective fault-finding when
required.
e. Operational separation of high-risk tissue
instruments from other sets has been achieved
without apparent error.
f. Operational separation of those sets used with
children born after 1 January 1997 has proved
fully effective in the protection of those children
against the use of uncontrolled instruments in
neurosurgery.
g. The use of supplementary instruments in neuro-
and PO surgery and even in other surgical areas
has been markedly reduced and where use of
supplementary instruments is necessary, it can
be identified through use of the record-keeping
system.
Pilot conclusions
A62 Large surgical care providers are confronted with
substantial problems in ensuring instrument set
stability and the minimisation of supplementary
instrument use, partly owing to their high
throughput of patients, both generally and in the
high-risk tissue-related services. Inappropriate or
outdated set design is shown to add significant
challenges to those inherent in large-scale
instrument management.
A63 The redesign of instrument sets to better match
clinical need and the simplification of the clinical
procedure categorisation techniques applied gives
rise to larger sets but these are very much more
easily managed and exhibit much improved
stability in terms of instrument retention.
A64 The use of simple colour-coding techniques to
differentiate between high-risk instrument sets and
those in general use has proven viable and offers
near-complete insulation against movement of
instruments between the high- and other risk
category work. Similarly, colour-coding has
demonstrated a high level of reliability in ensuring
that those sets used with younger patients are well-
protected from inadvertent use with the older
cohort. However, the NICE criteria for the post 1
January 1997 group include other factors such as
whether the patient has been subject to previous
neurosurgery or (applying ACDP-TSE guidance)
has had a large number of blood transfusions.
Therefore scope for error in the classification of a
child remains.
Single-instrument tracking and
management using a commercial
decontamination service provider
A65 Centre involved: Birmingham Childrens Hospital
NHS Trust.
Aims and objectives
A66 This pilot was designed to investigate practical
issues surrounding the implementation of NICE
IPG 196 (2006) guidance, but in the context of a
commercial contract for the external supply of
decontamination services as opposed to the internal
SSD arrangement at GOSH/UCHL and Newcastle
upon Tyne Teaching Hospitals NHS Trust.
36
A67 Birmingham Childrens Hospital (BCH) is part of
the pan-Birmingham Group that comprises eight
hospitals, all of which employ a decontamination
services provider under contract.
A68 The specific objectives of the pilot are:
a. Limitation of instrument migration between
sets via implementation of single-instrument
tracking for neurosurgical instruments
throughout the use/decontamination cycle.
b. Instrument set separation for patients born
before and after 1 January 1997 and CJD at-risk
patient identification protocols for use with this
group.
A69 BCH offers advanced neurosurgery and posterior
ophthalmic work, but exclusively employs single-
use instruments for the latter, so the scope of the
pilot in terms of reusable instruments is limited to
neurosurgery instruments.
Method and approach
A70 Supplementary instruments are regularly used at
BCH and the other trusts in the pan-Birmingham
Group. This may in part be due to the
decontamination pricing structure in effect at the
decontamination services provider, which is
organised in bands based on how many instruments
are in a tray. Decontamination staff have observed
that trays tend to be filled to the maximum number
possible within a given pricing band and further
supplementary instruments used as necessary, as
these are relatively inexpensive to have
decontaminated.
A71 In the current arrangement, instruments are
tracked at tray level at several stages throughout the
transport, initial inspection, washing/disinfection
and sterilization cycle, then again onto outbound
transport and at least on arrival at, and collection
from, stores at BCH. There are facilities to allow
more detailed tracking within BCH but these are
not presently being exploited.
A72 Trays of instruments are assigned GS1 codes by the
decontamination services provider and these persist
throughout the lifetime of the tray. These codes are
linked to records detailing the contents of the tray.
Supplementary instruments are also assigned GS1
codes that describe the type of instrument but these
codes are not permanent and are reassigned after
the instruments are returned for reprocessing. Each
item, whether a complete tray or a supplementary
instrument in a peel-pouch, has a label that
includes two peel-off 2D data matrix stickers,
carrying the GS1 code, which are used by BCH to
manually attach to the decontamination services
providers receipts and to the patients notes. This
paper-based system provides the only traceability to
the patient in the pre-single-instrument tracking
phase.
A73 Loan instrument sets are tracked in the same way,
but they present additional challenges to
maintaining set stability as anecdotal evidence
suggests that loan instruments may be further
borrowed and possibly used at other sites whilst on
loan to a specific trust. Instruments missing from
any set are noted on the labels printed by the
decontamination services provider, which also
sends notification emails to BCH each time set
contents are checked during reprocessing. At BCH,
the decision is made whether to proceed with the
use of the set without the instrument(s) or to
quarantine the set until the missing instruments are
found and repatriated to it, a process that is
managed manually.
A74 In preparation for the implementation of single-
instrument tracking, BCH and its decontamiantion
services provider spent a considerable period
evaluating instrument marking options, as it was
essential that the marking should not interfere with
either use or reprocessing of the instruments. The
solution chosen was to laser-etch a 2D matrix code
onto each instrument, a system that is flexible in
the range of instrument sizes that can be
accommodated, with readable codes down to 1.1
mm. Initial trials have shown that these codes are
not always easy to scan. Moreover, these etched
patterns wear off over time, especially on smaller
instruments, lasting typically a matter of months.
A75 An upgrade of the tracking software used by both
the trust and the provider was also necessary to add
support for single-instrument tracking. The
decontamination services provider has also had to
address staffing issues relating to the additional
workload that scanning each individual
neurosurgical instrument will entail, and logistical
challenges in respect of integrating a single-
instrument tracking stream within its existing tray-
level tracking workflow.
A76 Separation of instrument sets for the patient groups
born before and after 1 January 1997 involved the
purchase and laser-etching of four new sets of
neurosurgical instruments for use on the latter
group. These new sets are further identified by the
37
addition of a yellow coating to the handle of each
instrument. The labels attached to reprocessed trays
of the new neurosurgical instruments also add the
text post-1997 to the description of set contents;
this is reviewed in the preparation room against the
who checked list and again by the scrub nurse in
theatre.
A77 The identification of CJD at-risk patients to ensure
appropriate usage of the new neurosurgical
instrument sets has resulted in the development of
a checklist that hospital staff can complete using
information determined during routine clerking. A
CJD-specific questionnaire had been under
development but was abandoned as BCHs
governance services were concerned that it would
cause unnecessary anxiety and would be difficult to
administer to the hospitals patient population,
many of whom do not have English as a first
language.
A78 If a patient born after 1 January 1997 requires a
high-risk procedure, the new neurosurgical
instruments are used, provided that the patient has
not already undergone surgery with an older set of
instruments at BCH or at another hospital where
the CJD risk status of the instruments used is
unknown. Patients who have received multiple
blood products and are in the at increased risk for
public health purposes category, such as
haemophiliacs, are excluded from use of the new
neurosurgical instrument sets, though BCH has
been able to confirm that Octaplas, a blood plasma
product prepared from pooled blood donations,
does not count towards patients transfusion
histories. A consideration by BCH of types of
neurosurgery patient suggests that very few neuro-
oncology patients receive large amounts of blood
products and then require further neurosurgery: a
maximum of one per year.
A79 It is also possible that severe trauma cases could also
require high-risk surgery after receiving large
quantities of blood products but this would be a
very rare event indeed.
A80 The single-instrument tracking went into effect
from 1 January 2012. This date was chosen as an
easily remembered point for both BCH and
decontamination provider staff to switch to the
new procedures.
A81 The identification of the new sets of neurosurgical
instruments for the post 1 January 1997 cohort is
in place and working well. Although this measure
cannot reveal whether an instrument has migrated
between post 1 January 1997 sets, it does prevent
undetected mixing of high- and low-risk sets, in
accordance with NICE IPG 196 guidance. As a
childrens hospital treating patients of up to 18
years of age and generally not admitting new
patients of more than 16 years, BCH will soon
reach the point where its entire patient population
will be in the post 1 January 1997 group, though
there will continue to be issues regarding patients
previously treated with older instruments or at
other hospitals.
A82 BCH anticipates having to maintain separate
instrument pools for a further 1520 years,
although a progressively larger proportion of
patients will be treated with the new instrument
sets.
Pilot conclusions
A83 Simple instrument colour-coding akin to the
scheme adopted in Newcastle (see link below)
appears to be a robust solution for maintaining
separate pools of instruments for sectors of the
population born before and after 1 January 1997,
and should provide strong CJD protection for the
younger cohort, provided that patient CJD risk
categorisation is carried out correctly. The system
has to be designed to err on the side of caution and
thus may exclude CJD-free patients from access to
the new instruments because they have previously
had high-risk procedures performed at BCH or
elsewhere with instruments whose risk status is
unknown. It is possible that over time as this aspect
of NICE IPG 196 guidance is more widely adopted
and recorded, more repeat patients could be given
access to the new instruments.
A84 What this system alone cannot do is detect or
prevent instrument migration between sets within
the pre or post 1 January 1997 groups, or provide
traceability to the patient beyond the manual
sticker-based approach described above. It is
anticipated that the introduction of single-
instrument tracking in 2012 will address these
aspects of NICE IPG 196 guidance. A reappraisal
of set redesign to reduce or ideally eliminate the use
of supplementary instruments as carried out in
Newcastle (see paragraph A45) would require a
joint process between BCH and its
decontamination services provider that would
almost certainly have implications for the latters
38
business with other trusts within the pan-
Birmingham group.
Protein quantification using
epifluorescence scanning
A85 Centres involved: University of Edinburgh/Royal
Infirmary of Edinburgh.
A86 The in situ protein-detection techniques developed
by Dr Helen Baxter, Dr Anita Jones and Professor
Robert Baxter at the University of Edinburgh were
established out of research into the efficacy of
radio-frequency low-pressure gas-plasma cleaning
and decontamination methods. These methods are
capable of removing residual contamination on
instruments to a level where no organic residues
can be detected by scanning electron microscope
(SEM), so a more sensitive detection technique was
required. This led to the development of an
epifluorescence-based scanning technique that is
now being used to assess protein contamination
levels on reprocessed surgical instruments supplied
by the Royal Infirmary of Edinburgh.
Aims and objectives
A87 The aim of the pilot was to establish and validate a
means of quantifying residual contamination on
reprocessed instruments that was sufficiently
accurate, practical and robust for use in an SSD to
reduce risk of transmission of prions via surgical
instruments.
A88 The three objectives within this were to:
a. determine a statistically valid average value for
residual contamination on instruments
reprocessed using current washingdisinfection
processes that were considered fit for reuse
under current testing regimes;
b. determine an acceptable threshold value for a
clean instrument in terms of the new protein
detection and quantification technique;
c. develop/reconfigure the detection device
software to yield a traffic light.
Method and approach
A89 The underlying principle for protein detection in
this pilot was the excitation and subsequent
detection of fluorescence of proteins labelled
through reaction with fluorescein isothiocyanate
(FITC). Test discs of stainless steel and surgical
instruments to be scanned were immersed in a
solution of FITC for five minutes, rinsed in water
to remove excess reagent and allowed to dry.
A90 The Epifluorescent Surface Scanner (EFSCAN) was
built in partnership with Edinburgh Biosciences
Ltd and comprised a scanning bed over which an
optical fibre scanning head linked to a
photomultiplier tube was moved under computer
control to build up (pixel-by-pixel) a 2D image of
the scanning area. This process takes approximately
14 minutes at the higher of two available resolution
settings. Software captures and processes the
fluorescent intensity data from each scan site,
equivalent to an area of 0.5 mm
2
. Initial tests were
conducted using stainless steel tokens inoculated
with bovine serum albumin (BSA) before moving
onto a selection of 42 instruments at the end of
their usable life donated by the Royal Infirmary of
Edinburgh.
A91 Processing of the 2D fluorescence intensity data
enabled 3D plots to be made to visualise the
distribution of protein contamination and in
locating hot spots of unusually high contamination
and relating them to features of the scanned
instruments structure. Calibration of the system
enabled protein concentration-per-pixel to be
established. Further calculations converted these
values into absolute protein concentrations,
typically in the ng/mm
2
range, which were then
used to calculate total and averaged protein levels
over the scanned parts of the instrument. Work has
been done to relate these measured values to
washer-disinfector validation tests based on visual
assessment in order to help define a scale for
measurement optimisation.
A92 There are continuing deliberations over how the
data should be used to assess instrument cleanliness
in terms of total load, averaged or hot spot values
and how these relate to a broad initial aim of
producing a hundredfold improvement over visual
methods. Progress has been made towards defining
thresholds for a traffic-light system, in which initial
values of less than 1.5 ng/mm
2
averaged over the
scanned surface rates a green (suitable for use),
more than this value a red (not suitable for use,
process and test again) and any individual hot spot
in excess of 10 ng/mm
2
found in an otherwise
green scan will trigger an amber alert. Applying
these threshold values to a sample of 42 reprocessed
instruments from the Royal Infirmary of
Edinburgh SSD produced a 93% pass rate, though
39
seven instruments had hot spots, four of them in
the group that passed on average protein
concentration levels.
Pilot conclusions
A93 The EFSCAN project has shown that this
technique can locate and quantify protein
contamination on instruments down to very low
levels via a process that is relatively simple to set up
and operate. Optimisation for a specified
measurement range is a logical next step but work
remains to be done in defining what the target
range should be. Measurements and statistical
analysis of a larger sample of surgical instruments
from the Royal Infirmary of Edinburgh SSD
should help establish this.
A94 As with the Graet Ormond Street Hospital
(GOSH) and Southampton pilots, an investigation
into toxicology is required before scanned
instruments can be returned to the Royal Infirmary
for reuse. While fluorescein is considered safe and
indeed used in some surgical procedures, it is
necessary to investigate the possible effects of
derivatives. It is not anticipated that this will raise
any significant issues as the quantities of protein are
at worst in the submicrogram range, virtually all of
which is removed by subsequent washing.
A95 Significant improvements in the speed of the
EFSCAN scanning unit could potentially be made
if the design were to be developed for
commercialisation.
A96 Current issues being addressed are the software
interface design and measurement techniques, in
terms of how much data would be presented to the
SSD user, particularly in the case of an amber
result and whether the lower-resolution (and
therefore faster) scanning mode would be able to
detect hot spots. Linking scanned instrument data
to GS1 coding for single-instrument tracking
should be a relatively straightforward exercise and
would enable a variety of data, from simple pass/
caution/fail verdicts to complete fluorescent image
capture, to be associated with the instrument for
record-keeping and audit purposes.
Protein quantification using EDIC/
epifluorescence microscopy
A97 Centres involved: University of Southampton,
University Hospital Southampton and
Southampton General Hospital.
A98 The pilot work at Southampton is based on a
technique called EDIC microscopy, originally
developed for detection and inspection of biofilms
and bacteria on surfaces. The University team, led
by Professor Bill Keevil, has been carrying out a
project funded by DH to develop a protocol for the
detection of protein using this technique.
Aims and objectives
A99 As with the other protein detection pilots (GOSH/
Queen Mary University of London, and Edinburgh
University), the specific objectives included:
a. To determine the effectiveness of the technique
in question both in terms of locating and of
quantifying residual protein on reprocessed
b. To assess the operational impact of the potential
adoption of the new technology in terms of
SSD practice and subsequent use of instruments
sampled from the SSD.
c. To provide guidance recommendations for the
use of the new methods.
d. To generate information on capital,
implementation and operation costs.
Method and approach
A100 As the EDIC microscopy had already proven to be
a powerful tool for biofilm and bacteria-related
work, the requirement was to find a suitable
labelling technique that would provide sufficient
sensitivity and specificity for protein detection.
A101 Sypro Ruby, a highly-sensitive fluorescent stain, was
selected as it is capable of revealing proteins in sub-
nanogram quantities per mm
2
and, through use of
a thiazole marker (which causes light of a different
wavelength to be emitted), is also able to detect
plaque proteins, particularly relevant because vCJD
forms this type of protein. With no direct test for
prions yet available, detecting prion-associated
amyloid is one step more specific than a generic
protein test.
A102 In the context of testing for protein residues on
reprocessed surgical instruments, the ability to test
directly for the more hydrophobic proteins, which
may be expected to be more resistant to removal in
the washer-disinfector process, is additionally
valuable as a tool in testing the efficacy of various
types of cleaning process.
40
A103 The EDIC/epifluorescence (EDIC/EF) technique
was used in conjunction with a digital camera to
enable the capture of photomicrographs, firstly of
316-grade stainless steel coupons that had been
dosed with varying amounts of mouse-brain
homogenate. From these, the threshold of detection
was established via a panel of eight independent
observers. Inspection at multiple points of a variety
of surgical instruments that had been through
standard washer-disinfector cycles enabled a
contamination index (CI) to be constructed,
ranging in numerical score from 1 (no detectable
protein contamination) to 4 (gross contamination).
These values have been correlated against observed
particulate height and width to yield corresponding
protein concentrations, ranging from
042ng/mm
2
for a CI of 1 to >4.2 g/mm
2
for a
CI of 4.
A104 A variety of further experiments involving the use
of the EDIC/EF technique has subsequently been
carried out. These include:
quantification of the sensitivity of established
protein detection with ninhydrin and biuret
tests;
residual protein measurement on 260 surgical
instruments;
measurement of bioburden on diathermy
instruments;
a demonstration of amyloid-specific detection at
attomole levels;
a comparison of visual assessment of instrument
cleanliness and protein contamination as
measured using EDIC/EF microscopy;
a comparison of protein contamination of
reprocessed instruments when handled by
operators wearing gloves against handling with
bare hands; and
a comparison of the cleaning efficacies of a
number of commercial cleaning chemistries
currently used in washer-disinfectors.
A105 Investigations into the effect of drying time,
maintenance of a moist environment and/or the
use of pre-soak treatments on washer-disinfector
cleaning efficacy have also been made and the
results published.
A106 The published work from this pilot shows that the
EDIC/EF technique for in situ protein detection is
both rapid and sensitive, particularly compared to
established swab-based protein detection methods.
Because the microscope operates at a relatively large
distance from the subject (compared to other
microscopy applications), it is possible to work
with the irregular shapes and contours or real
surgical instruments without the need for oil or
cover slips.
A107 The various experiments described above have
yielded a wide range of findings. In brief they
include:
The EDIC/EF technique with Sypro Ruby stain
enables detection of residual proteins in
concentrations between approximately 85 and
175 pg/mm
2
(at minimum level of detection
(MLD) of 50 and 75 respectively).
The minimum detection levels for ninhydrin
and biuret tests were found to be 9.25 and
6.7g (respectively, both at MLD75), while
visual assessment of contamination, although
found to correlate well with measured levels for
simple instruments, was prone to severely
underestimating contamination in more
complex ones.
A study of 260 surgical instruments that had
been reprocessed and were deemed clean
showed that over 60% had a protein soiling
level of between 0.4 and 4.2 g/mm
2
. This
study also found non-protein crystalline
deposits on the instruments. These may
originate from washer-disinfector chemistry and
it appears that they act as preferential
attachment sites for protein residues; the
toxicology of the deposits is as yet unknown.
Instrument handling by cleanroom staff without
gloves showed a five-to tenfold increase in
protein present on reprocessed surgical
instruments compared with those handled by
staff wearing gloves, although protein added this
way is unlikely to pose a risk to patient health;
The comparison of cleaning chemistries showed
that all the tested products were only partially
effective under the manufacturers
recommended conditions, with a considerable
variation in efficacy between products. Brain
homogenates from mice infected with the ME7
strain of scrapie were used for testing on
stainless steel tokens and it was observed that
PrPSc (scrapie prion protein) constituted the
bulk of residual protein after passing the
41
contaminated tokens through the recommended
washer-disinfector cycles; neurosurgical
instruments stained for comparison with the
tokens were found to harbour amyloid and
general protein contamination.
Pilot conclusions
A108 The pilot study has shown that EDIC/EF
microscopy is a sensitive and versatile measurement
technique, able to detect and quantify plaque
proteins of the type associated with vCJD in
addition to more general protein contamination.
Through use of visible light techniques, additional
types of contamination on reprocessed instruments
and the interaction between these and protein
residues may be observed, enabling a more
complete picture of instrument condition to be
gained.
A109 Further work at the SSD at Southampton General
Hospital is being carried out to evaluate current
processes across several different washer-disinfector
models and cleaning chemistries, both in absolute
terms and comparing to ninhydrin/biuret testing. A
suitably equipped microscope had been installed
and staff were being trained in its operation;
protocols for instrument testing were being
developed and the toxicology of Sypro Ruby will be
further investigated as part of this process, though
it is thought to be non-toxic at any concentration
likely to be encountered in this application. Lab-
based experimentation with a lower-power lens is
also taking place to establish limits of detection
with a wider field of view.
42
B1 This report describes the aims, methodology,
findings and recommendations from a survey of
surgical instrument decontamination in 30 selected
NHS and private healthcare providers and their
associated decontamination facilities in England
where neuro- and posterior ophthalmic (PO)
surgery are carried out. It also briefly describes
related work based on the findings of the survey
that was carried out from late 2008 to December
2010 at three sites chosen to pilot improvements in
risk control related to surgical instrument
management and decontamination (Appendix A
contains the finalised reports from the pilot
studies).
B2 The survey was designed to investigate the extent to
which risk-reduction measures aimed at minimising
the possibility of prion transmission via surgery
involving high risk (in vCJD infectivity terms)
tissues have been applied. Specific reference is made
to the implementation of guidance contained
within the NICE IPG 196 (2006), which deals
with instrument management in pursuit of risk
reduction via the retention of instruments within
stable neurosurgical and PO sets. NICE IPG 196
(2006) also recommends that separate and
identifiable instrument sets for patients born before
and after 1 January 1997 are provided and
rigorously maintained. Further advice from the
Advisory Committee on Decontamination Science
and Technology (ACDST, formerly the Engineering
and Science Advisory Councils Transmissible
Spongiform Encephalopathy Working Group,
ESAC-TSE WG, and disbanded at the end of
2010) is incorporated. This survey also includes
compliance with EN/ISO/BS engineering standards
which, whilst not specific to prion transmission, are
thought from experimental evidence to contain
elements which have an effect on such risk.
B3 ACDP-TSE RM has published an extensive series
of guidance documents aimed at risk control in
connection with prion transmission, some of which
concern surgical or other interventional procedures.
The implementation of this guidance has been
incorporated investigated closely in this survey.
B4 The initial field survey was carried out in mid-2008
and involved joint research teams comprising DH
representatives and local staff gathering information
via a detailed questionnaire. The results were
analysed using a figure-of-merit approach to weight
the response data relating to the various measures
under investigation according to their importance
and effectiveness in reducing the risk of prion
transmission.
B5 The principal findings are that while the EN/ISO/
BS decontamination standards are found to be
satisfactorily applied, the implementation of NICE
IPG 196 (2006) was relatively inconsistent,
particularly in respect of adopting separate surgical
instrument sets and streams for use with children
born after 1 January 1997. Specifically, very few
centres have simultaneously combined the
requirements for new instrument sets for this age
group with instrument tracking and adequate
protection against instrument leakage. Further, no
centre, outside the pilots, has achieved the full
NICE IPG 196 risk reduction benefit intended.
B6 The implementation of ACDP-TSE RM guidance
was also inconsistent, though two-thirds of centres
achieved a high standard of compliance such as to
generate a reasonable contribution to risk control.
B7 Another area of concern is a lack of testing of both
electrical safety and calibration, especially with
regard to diathermy equipment. Although not
specifically related to prion transmission risk
reduction strategy, this is an area that requires
urgent attention.
B8 The findings of this survey and subsequent
development work at the pilot sites form a
substantial part of the evidence base for the
guidance now provided in CFPP 01-01.
Combining the survey findings with the
subsequent guidance implementation pilot work
makes it possible to deliver a more coherent policy
and guidance package.
The National Decontamination Survey can be accessed
via this link.
Appendix B: The National Decontamination
Survey report
43
C1 This guidance has been written for care
commissioners, care providers and care quality
regulators to improve standards in the
decontamination of surgical instruments and to
ensure that Essential Quality Requirements are met
by every hospital and medical facility conducting
surgery in England, and that healthcare
organisations have a plan in place to move towards
Best Practice, where possible, according to the
needs of the patients that they deal with.
Why the need for the guidance?
C2 Most people who go to hospital for a surgical
procedure have a good experience and outcome.
However, in some instances, the experience and
outcome may not be as expected for a number of
reasons. Those reasons involving surgical
instruments include:
The instruments may not have been sterilized
adequately, meaning that the patient may have
been exposed to infectious microorganisms and
may develop an infection as a result.
Some people may have been operated on using
instruments that, subsequently, are found to
have been used on a patient who has developed
CJD (an infectious neuro-degenerative disease)
or a related disease. These patients must be
identified and informed of the risk of infection
and developing CJD in the future.
Key surgical instruments required for a
procedure may be missing from the instrument
set. This usually results in operations being
cancelled at short notice with great
inconvenience to the patient.
Instruments may be dropped during surgery,
meaning that surgical procedures may need to
be stopped or delayed before they have been
finished.
Patients who have been told they are at risk of
developing CJD, through exposure to the
infectious agent either from contaminated
instruments or through contaminated blood
products, may find that the surgical procedures
they need are cancelled or postponed while a
risk assessment is made and provisions to isolate
the instruments following the surgery are made.
C3 The guidance is intended to improve patient
outcomes by requiring that systems are put into
place to reduce infection, to ensure risk assessments
are undertaken for all areas of the sterilization/
decontamination process and to ensure that
instruments remain in their sets by tracking them
at all times.
How does this affect me?
C4 As a patient who may need a surgical procedure, or
as a carer for someone who may need surgery, it is
important that you get the best treatment possible
and that you feel that everything is being done to
safeguard your well-being.
Am I at risk of CJD infection from
surgical instruments?
C5 The infectious agent that causes CJD and related
diseases is made of protein and is very difficult to
destroy. It clings to the surface of instruments and
most hospital sterilizers cannot guarantee that they
have removed all the protein from the surface of
instruments and destroyed the agent. If people who
already have CJD and are not aware of it have
surgery, they could potentially infect the
instruments used during the surgery and this
infection can then potentially be passed on to other
people. Steps are being taken to develop new
technologies and better sterilization techniques to
remove and destroy the agent, and this guidance
covers the adoption of such technology as it
becomes available. This aims to make surgery as
safe as possible for the patient.
Appendix C: A patient and public perspective
44
What is being done to improve patient
safety?
C6 The guidance implements a number of quality
standards and guidelines from regulatory and
learned bodies to ensure that:
surgical instruments are coded and tracked and
remain within their instrument set;
surgical instruments can be traced back to the
patients they have been used on;
extra instruments required for a particular
procedure are used only once or kept within the
set for that procedure;
a separate pool of instruments is kept for
children born after 1 January 1997 to make sure
that they are not exposed to the CJD agent;
sterilization procedures and facilities within the
hospital are fit-forpurpose and meet Essential
Quality Requirements;
where high-risk surgical procedures are required
(for example, neurosurgery or post-ophthalmic
surgery), appropriate risk assessment is carried
out and reflected in the local policies;
the method used for sterilization is suitable to
the instrument and will not damage the
instrument;
hospitals carry out risk assessments wherever
possible to prevent failures in the
decontamination procedures.
45
Standards relevant to decontamination
processes and equipment
BS EN ISO 11737-1. Sterilization of medical devices.
Microbiological methods. Determination of a population
of microorganisms on products.
BS EN ISO 11737-2. Sterilization of medical devices.
Microbiological methods. Tests of sterility performed in
the definition, validation and maintenance of a
sterilization process.
BS EN ISO 14937. Sterilization of health care products.
General requirements for characterization of a sterilizing
agent and the development, validation and routine
control of a sterilization process for medical devices.
BS EN ISO 17665-1. Sterilization of health care
products. Moist heat. Requirements for the development,
validation and routine control of a sterilization process
for medical devices. (This includes porous load and fluid
sterilizers (except where used for medicinal products),
and sterilizers for unwrapped instruments and utensils.)
BS EN 285:2006+A2. Sterilization. Steam sterilizers.
Large sterilizers.
BS EN 13060. Small steam sterilizers.
BS EN 1422:1997+A1. Sterilizers for medical purposes.
Ethylene oxide sterilizers. Requirements and test
methods.
BS EN 14180:2003+A2. Sterilizers for medical purposes.
Low temperature steam and formaldehyde sterilizers.
Requirements and testing.
BS EN ISO 15883-1. Washer-disinfectors. General
requirements, terms and definitions and tests.
BS EN ISO 15883-2. Washer-disinfectors. Requirements
and tests for washer-disinfectors employing thermal
disinfection for surgical instruments, anaesthetic
equipment, bowls, dishes, receivers, utensils, glassware,
etc.
BS EN ISO 13485. Medical devices. Quality
management systems. Requirements for regulatory
purposes.
Standards relevant to decontamination
management
BS EN ISO 13485. Medical devices. Quality
managements systems. Requirements for regulatory
purposes.
Standards relevant to safety
requirements for decontamination
equipment
BS EN 61010-2-040. Safety requirements for electrical
equipment for measurement, control and laboratory use.
Particular requirements for sterilizers and washer-
disinfectors used to treat medical materials.
BS EN ISO 13849-2. Safety machinery. Safety-related
parts of control systems. Validation.
Standards relevant to medical devices
BS EN 556-1. Sterilization of medical devices.
Requirements for medical devices to be designated
STERILE. Requirements for terminally sterilized
medical devices.
BS EN 556-2. Sterilization of medical devices.
Requirements for medical devices to be designated
STERILE. Requirements for aseptically processed
medical devices.
BS EN 1041. Information supplied by the manufacturer
of medical devices.
BS EN ISO 17664. Sterilization of medical devices.
Information to be provided by the manufacturer for the
processing of resterilizable medical devices.
BS EN ISO 14971. Application of risk management to
medical devices.
Appendix D: Standards relevant to
decontamination
46
Health Act Code of Practice.
NICE IPG 196 (2006).
Choice Framework for local Policy and Procedures 01-01
Management and decontamination of surgical
instruments (medical devices) used in acute care. Part B
Common elements.
instruments (medical devices) used in acute care. Part C
Steam sterilization.
instruments (medical devices) used in acute care. Part D
Washer-disinfectors.
instruments (medical devices) used in acute care. Part E
Alternatives to steam for the sterilization of reusable
medical devices.
The Health and Social Care Act 2008: Code of Practice
on the prevention and control of infections and related
guidance.
Medical Devices Directive.
Revision to the Medical Devices Directive.
CQC Guidance about compliance.
GS1 coding.
NHS Operating Framework 2012/13.
Medical Devices Regulations (MDR) 2002.
BS EN ISO 13485.
Executive Letter EL(98)5.
Decontamination Services Agreement.
In-vitro Diagnostic Devices Directive.
Active Implantable Medical Devices Directive.
Health and Social Care Act 2008 (Regulated Activities)
Regulations 2010.
European Union website.
MHRA.
CMO letter 2007/2.
CMO letter 2008/2.
Hilton and Ironside (2003).
Guidance from the ACDP-TSE RM Subgroup.
CJD Incidents Panel.
ACDP-TSE RM Annex J.
ACDP-TSE RM: TSE Agents. Safe Working and the
Prevention of Infection Part 4.
ACDP-TSE RM guidance on infection control of prion
diseases (Part 4).
ACDP-TSE RM guidance Annex L.
IHEEM AE(D) register.
Institute of Decontamination Sciences (IDSc).
Institute of Healthcare Engineering and Estate
Management (IHEEM).
ESAC-Pr report.
References
National Decontamination Survey
Report 20082010
A survey of instrument management and decontamination
in high-risk tissue surgery centres
1
Contents
Executive summary 2
1.0 Introduction and background 9
2.0 Methodology 16
3.0 Findings 25
4.0 Discussion and conclusions 47
5.0 Recommendations 51
6.0 References 53
Annex 1: Figure of merit
analysis method 59
2
Executive summary
Introduction
The principal purpose of the National Decontamination Survey (NDS) 200810
was to determine the progress made by neuro- and posterior ophthalmic surgical
healthcare providers and decontamination service providers in implementing:
National Institute of Clinical Excellence (NICE) IPG 196 (2006) Patient
safety and reduction of risk of transmission of Creutzfeldt-Jakob disease
(CJD) via interventional procedures prion transmission risk reduction guid-
ance; and
Advisory Committee on Dangerous Pathogens Transmissible Spongiform
Encephalopathy Risk Management subgroup (ACDP-TSE RM) guidance on
specifc risk control related to patients at risk of CJD and variant CJD (vCJD).
This includes TSE Infection Control Guidance Annex J, which is concerned
with patients who are to have neuroendoscopy or surgery on tissues consid-
ered high risk in terms of potential prion transmission.
In addition, the survey aimed to assess compliance with decontamination quality
systems and engineering standards described in Health Technical Memorandum
(HTM) 2010 Sterilization and HTM 2030 Washer-disinfectors.
The survey was designed to assist in rening the risk estimates related to potential
further spread of human prions via surgical instruments. To this end, the survey
results were processed using a fgure-of-merit (FOM) method, which is designed to
recognise progress and to highlight risk-related failings and omissions.
The key questions used to interpret the survey data were developed with advice
from the Engineering and Science Advisory Committee into the decontamination
of surgical instruments including prion removal (ESAC-Pr) (subsequently the Advi-
sory Committee on Decontamination Science and Technology (ACDST) prior to its
disbanding at the end of 2010) and ACDP-TSE RM committee chairs, supported by
appropriate learned and professional bodies.
The survey covered 30 centres offering neurosurgical and/or invasive posterior
ophthalmic procedures, including both NHS and private providers. These were se-
3
lected by reference to the appropriate learned and professional bodies, with a view
to capturing a large proportion of those carrying out invasive procedures on tissues
considered to be high-risk in prion transmission terms, specifcally the brain (sub-
dural), retina and optic nerve. These tissues can carry a level of infectivity such that
if surgery is conducted on a patient who is an unsuspected carrier of vCJD or other
prion disease, the risk of onward transmission via the instruments used on that
patient is signifcantly greater than for surgery involving other anatomical areas.
For this reason, the survey does not offer an overview of general acute unit surgical
instrument decontamination as a whole, and should not be regarded as such.
Note:
The term centre is used throughout this report. In most cases, it refers to a
single site upon which both neurosurgery and/or posterior ophthalmic work is
performed and the decontamination of the instruments used is also conducted.
However, in some instances, a centre may conduct the surgery with the decon-
tamination being performed elsewhere.
The feldwork for the survey was conducted in 2008, with supporting pilot studies
and analysis completed in 2010. Site visits were used for the survey in both oper-
ating departments and the sterile services departments (SSDs) that support them.
Assistance was provided by the Health Protection Agency (HPA) and the service
providers themselves. Independent and industry-based engineers specialising in
surgical instrument decontamination played an important role, particularly in the
survey of quality systems and engineering controls.
A series of pilots was established alongside the survey and continued to run sub-
sequently, with the aim of investigating the effcacy and practicality of a range of
methods for reducing prion transmission risk. Areas investigated include single (ie
individual)-instrument tracking and tracing, keeping instruments moist after use
(Great Ormond Street Hospital for Children NHST (GOSH)/ University College Hos-
pital London (UCHL)/ Queen Mary University of London), updating the choice of
instruments within sets to properly reect the evolving procedures for which they
are used (Newcastle upon Tyne Hospitals NHST), high sensitivity residual protein
localisation and quantifcation (GOSH/ UCHL/ Queen Mary, Southampton Univer-
sity, Edinburgh University). Findings from the survey and experience gained during
the pilot programmes have provided key parts of the evidence base informing the
new guidance issued in Choice Framework for local Policies and Procedures (CFPP)
01-01.
4
Timing of publication
The timing for publication of this survey report has been set by the Department of
Health (DH) so that an holistic picture can be presented to the reader by combin-
ing the 2008 survey visit fndings with the subsequent work by the guidance im-
plementation pilots. This enhanced document has been used as a signifcant part
of the evidence base for CFPP 01-01, to which it is annexed; the publication of the
survey work and guidance together makes it possible to deliver a more coherent
policy and guidance package.
Main ndings
The ndings show that the great majority of centres are successfully implement-
ing surgical instrument reprocessing quality system guidance. While an impact on
prion removal or infectivity reduction is yet to be demonstrated directly, evidence
from the pilots supports this assertion. There are positive fndings on the benefts
of keeping used instruments moist prior to decontamination and from the use of
improved protein quantifcation techniques which have enabled the subsequent
refnement of washing-disinfection procedures and detergent choice.
The survey evidence also suggests that certain aspects of decontamination guid-
ance, outside the engineering standards and quality systems implementation, are
better followed than others. In particular, the management and audit of instru-
ments when they pass between operational teams, for example between SSD and
operating theatre staff, are often weak. This is a key focus of the pilots as well as
the CFPP 01-01 guidance.
Implementation of NICE IPG 196 (2006) guidance
Implementation of NICE IPG 196 (2006) Patient safety and reduction of risk of
transmission of Creutzfeldt-Jakob disease via interventional procedures (NICE IPG
2006) guidance has not progressed as rapidly or fully as had been expected. Key
aspects of the guidance, such as the much-enhanced integrity of instrument sets
and the removal of the need for the use of supplementary instruments, are not
yet commonly in place (Figure 1). However, fexible neuroendoscope use is much
reduced, replaced by the use of rigid neuroendoscopes, in line with NICE IPG 196
recommendations.
5
The track-and-trace technologies, which enable individual instruments to be au-
dited and retained in their sets, are only implemented and working in a small num-
ber of centres. An alternative approach, pioneered at Newcastle Teaching Hospitals
NHST, based on redesigned and larger instrument sets as a means of eliminating
the use of supplementary instruments, has been shown to reduce their use to negli-
gible levels.
In addition, the NICE IPG 196 (2006) recommendation to introduce dedicated
instrument sets to prevent children born after 1 January 1997 from being exposed
to prion contamination during surgery have been implemented in very few centres.
Where they have, this was often without accompanying measures to ensure good
set integrity, so that overall risk reduction is not secured. Of the centres surveyed,
only those that were also pilots have achieved the full risk reduction intended by
NICE IPG 196 (2006).
Evidence suggests the letters from the Chief Medical Offcer (CMO) in support of
NICE IPG 196 guidance have raised the awareness of the need to implement the
guidance. However, this has not raised the rate of actual implementation. The ma-
jor pilot on this item of guidance was at Great Ormond Street Hospital.
Implementation of ACDP-TSE RM guidance
The guidance from ACDP-TSE RM on surgical prion transmission risk control for at-
risk patient groups is, by contrast to the NICE measures, well implemented by the
Figure 1. Implementation of NICE guidance on supplementary instruments in the
2008 survey
6
majority of centres surveyed. It is likely that this is exerting downward pressure on
risks, at least from those patients with a known risk of prion infection.
Decontamination process quality systems
The analysis related to quality systems and their implementation shows a strong
performance. The implication is that procedures and controls are suffciently robust
in all centres to permit a round of further improvement in decontamination-related
risk control. This would include improved protein removal and the implementation
of new anti-prion decontamination technologies once their application is better
understood.
Operational practices and electrical safety
Operational practices are a key aspect of decontamination and are central to main-
taining a continuously high quality of product output. Most centres are compliant
with their own local policies and procedures. However, a signifcant proportion of
centres suffer from a lack of instrument and safety device testing equipment, such
as that required for electrical safety checks on diathermy equipment, to ensure that
equipment is safe for use. The concerns are especially with regard to electrical haz-
ards from devices in direct contact with the patient.
Staff training and development
The survey suggests that most staff are trained to a suitable level in terms of the
operation of the equipment they use, but that there may be considerable scope for
broader training and professional development.
Facilities for instrument decontamination and management
The environment for decontamination and instrument management has not
improved as rapidly as the decontamination equipment itself. Many centres
have sub-optimal fow from dirty to clean and separation within this fow. Addition-
ally, centres fail to provide such simple facilities as wash-hand basins within instru-
ment inspection areas. Few centres have fully designated spaces for specifc tasks,
7
particularly those related to storage. Ventilation of the environment used for instru-
ment decontamination is often not compliant with existing guidance.
Key recommendations
Evidence from the survey strongly supports the view that the 30 selected centres
produce sterile instruments as required by the Health and Social Care Act 2008:
Code of Practice on the prevention and control of infections and related guidance.
Although the quality systems and standards supported by pre-existing DH guidance
are shown by the survey to be effectively implemented, many other guidance pack-
ages such as NICE IPG 196 (2006) are not. The following recommendations are
therefore based on correcting the existing signifcant areas of non-implementation
and applying further measures via the accompanying CFPP 01-01 guidance:
Strengthen NICE IPG 196 (2006) implementation. Evidence from the pilot
sites (see CFPP 01-01 Part A) supports the implementation of the further
guidance in CFPP 01-01, published with this report. This includes the need
for a greater emphasis on protein removal and prion risk-reduction aspects
of decontamination;
Carry out a local risk assessment for electrical instrument safety and calibra-
tion, with particular emphasis on diathermy and address any safety issues;
DH to consult with ACDP-TSE RM on enhancing the use of the latters guid-
ance now that good data on implementation has been established. ACDP-
TSE RM guidance for neuro-, posterior ophthalmic and general surgery is
referenced in CFPP 01-01;
Suitably optimise the use of washer-disinfectors. Initial and ongoing research
on protein removal in washing processes is well-supported by current qual-
ity systems implementation, making washer-disinfector optimisation both
feasible and worthwhile in the working environment;
Introduce audit programmes in all centres, particularly in those where im-
plementation of NICE IPG 196 (2006) and ACDP-TSE RM guidance is being
pursued;
Consider repeating the survey in two or more years time, to examine the
effect of implementing CFPP 01-01, as advised by learned bodies;
8
Determine appropriate parameters for the physical environment, including
ventilation of decontamination facilities, supporting the provision of further
design guidance (see Health Building Note 13 Sterile services department
for further information);
Advocate such simple improvements as the better provision of wash-hand
basins and operational protocols in order to raise hygiene standards in sterili-
zation providers (see Health Building Note 13 for further information);
Strengthen surgical instrument management, including the proposed new
role of Surgical Instruments Manager within all surgical centres in acute care,
with better protocols for implementation and audit, particularly for supple-
mentary or loan set instruments. For high-risk procedures, a link to patient
identity is necessary. The systems provided by NHS Connecting for Health
and Coding for Success are suitable for this purpose;
Introduce measures such as the improved audit procedures described in
CFPP 01-01 Part A to reduce the likelihood of single-use instrument reuse
due to migration into reusable instrument sets;
Emphasise to providers the need to apply current guidance on disposal of
single-use instruments (see Safe management of healthcare waste);
Review single-instrument tracking and set structure. Pilots at GOSH have
shown that single-instrument tracking is viable, whilst work at Newcastle
upon Tyne NHST has successfully demonstrated an alternative or enhance-
ment to single-instrument tracking via the use of larger instrument sets in
clinical groups, described in CFPP 01-01 Part A;
As part of a learning exercise from this survey, commercial contract terms
should comply with current and evolving decontamination guidance and be
addressed in arrangements for external surgical instrument decontamination
services. Pilot work at Birmingham Childrens Hospital (see CFPP 01-01 Part
A) where decontamination services are provided by an external commercial
contractor is likely to be helpful here.
9
1.0 Introduction and background
DH medical device decontamination improvement policies have usually focused on
secondary or tertiary acute surgical services, as this is where evidence suggests
that the major risks of infection transmission - particularly by surgical instruments
- exist. Much of this thinking was stimulated by continuing concerns over residual
protein contamination following decontamination, and the possibility that human
prions - specifcally variant Creutzfeldt-Jakob Disease (vCJD) - could be transmit-
ted in this way. The most recent guidance from NICE and ACDST draws renewed
attention to the prion issues, with a particular focus on high-risk tissues, including
those of the brain and the posterior eye.
In response to the concerns regarding prion risk, DHs Gateway Review Estates and
Facilities Division determined to carry out a survey on instrument management and
decontamination in some 30 centres that provide high-risk tissue procedures in
neuro- and complex posterior ophthalmic surgery.
The fundamental purpose of the survey was to determine the progress made by
healthcare organisations in implementing NICE IPG 196 and Advisory Committee
on Dangerous Pathogens Transmissible Spongiform Encephalopathies Risk Man-
agement subgroup (ACDP-TSE RM) guidance contained in Transmissible spongi-
form encephalopathy agents: safe working and the prevention of infection. These
measures are built upon the continued development of improved general surgical
instrument decontamination, based on BSi/EN/ISO engineering standards and
quality systems, the majority of which are now harmonised; this implies that these
standards now agree in terms of detailed content across the respective standards
organisations, thus removing previous conficts and confusion over defnitions.
A secondary goal of the survey was to help determine the risk of any possible fur-
ther spread of human prions via surgical instruments. Additionally, the survey aimed
to assess the centres compliance with decontamination quality systems designed to
ensure satisfactory engineering within the use/ decontamination/ reuse cycle.
In 2008, DH carried out the feld-work for the frst part of a two-phase National
Decontamination Survey (NDS). The survey was timed to serve the evidence-gath-
ering programme for CFPP 01-01, which modernises decontamination guidance for
acute sector services.
10
A series of pilots was run at three centres - GOSH / UCLH, London, Birmingham
Childrens Hospital and Newcastle upon Tyne NHST - to test the protocols and
techniques utilised for the survey. Subsequent to the completion of this survey
round, steps were taken to convert these pilots to a new role. In this new role, the
pilots have investigated means of addressing key areas shown by the survey to be
in need of further development. DH has provided part funding to this new pilot
work in which survey ndings have been addressed by the formulation of new
guidance which has been tested within these pilot centres at both scientic and
practical levels. Within this report, new fndings derived from these pilots are pre-
sented alongside those from the original survey work.
It should be stressed that the survey was carried out for scientifc purposes, to assist
in the gathering of evidence useful in determining the magnitude of risks related to
any further spread of human prions via surgical instruments. The survey protocols
were developed to provide a representative picture of national neuro- and posterior
eye centres decontamination quality system effectiveness, rather than to examine
individual trusts or service providers performance.
This report describes the decontamination survey process, fndings and conclusions.
It makes recommendations to improve the quality of surgical instrument provision
and to reduce the risk of further spread of human prion diseases within the popula-
tion of surgical patients.
The timing for publication of this survey report has been set by DH so that a full
holistic picture can be presented to the reader. By publishing in 2012 it is possible
to take the 2008 survey visit fndings and combine them with the subsequent more
detailed work by the guidance implementation pilots. This enhanced document has
been used as a signifcant part of the evidence base for CFPP 01-01; the publica-
tion of the survey work and guidance together is seen as serving the needs of guid-
ance users when making choices within the framework offered.
The decontamination and surgical communities will benet from reading this report
in full, to reassure themselves of the progress made in decontamination of reus-
able medical devices, particularly in respect of the drive to implement quality sys-
tems, which has been underway since the late 1990s. The report will support both
the scientic community in establishing the direction of future research and DH in
policy and guidance development.
The ndings of the survey also provide a baseline against which to review imple-
mentation of DH and advisory committee guidance on decontamination, for the
11
assessment of future progress. Provisionally the survey is scheduled for repetition
two years after the publication of this report.
1.1 Policy and guidance environment
The NDS report is informed by a range of policy documents and independent guid-
ance from organisations such as DH, NICE, ACDP-TSE RM and ACDST. It has been
further supported by CMOs correspondence.
1.1.1 Department of Health Policy and guidance
In 2007, DH published a policy summary on the decontamination of reusable medi-
cal devices in healthcare organisations (Department of Health (2007) Clarifcation
and policy summary Decontamination of reusable medical devices in primary,
secondary and tertiary care sectors). This policy statement identifed that decon-
tamination services in healthcare establishments are required to provide a service
in accordance with the EEC (now EU) Medical Devices Directive (MDD), which is
adopted into UK law within the Consumer Protection Act as the Medical Devices
Regulations (MDR) 2002/4 (subject to current revision).
In accordance with the philosophy set out in DHs policy document, Shifting the
balance of power, and as further described in the 2007/8 NHS Operating Frame-
work, responsibility for achieving acceptable standards of care delivery, including
decontamination, lies with commissioners, individual trusts and provider organisa-
tions. The infuence of this policy is seen in the locally-decided nature of the decon-
tamination policies held by trusts and their service providers.
The MDR lays down a set of essential requirements that centre around ensuring
that reprocessed devices, including surgical instruments, are safe and ft for pur-
pose. In decontamination units, compliance is required in such key areas as the
control of processes and the working environment. Another essential requirement
for decontamination units is the use of a recognised quality management system,
such as the standard BS EN ISO 13485:2003 Medical Devices. Compliance with
these systems is rigorously investigated in this survey.
Quality standards defne the required characteristics of products and services. In
decontamination units, standards relating to quality systems, the working en-
vironment, safety, reliability and effciency of surgical instruments and ancillary
12
equipment are particularly relevant. Decontamination of reusable medical devices
is governed by a number of best practice quality standards and systems, whose
implementation is key to ensuring that products are safe and ft for purpose. This
approach forms much of the basis of CFPP 01-01 Parts AE.
1.1.2 The Health and Social Care Act 2008
The Health and Social Care Act 2008 established the Care Quality Commission
(CQC) to register, review, investigate and support improvements in healthcare
provision. The Health and Social Care Act 2008: Code of Practice on the preven-
tion and control of infections and related guidance (the Code) supporting this
Act is aimed at reducing HCAIs and sets out how the CQC will assess compliance
with Regulations made under section 20(5) of the Health and Social Care Act 2008.
Healthcare organisations are specifcally required by the Code to provide a safe
decontamination service for reusable medical devices.
1.1.3 CMOs letters
The CMO has to date published two professional letters drawing the attention of
centres providing neurological and posterior eye surgery to their responsibilities in
implementing NICE IPG 196 (2006) guidance. The frst letter, dated February 2007
reminded centres that they should be developing arrangements to implement NICE
guidance and set out DHs plans to issue further advice on decontamination in
2007. This advice is now incorporated into the CFPP 01-01 guidance package.
A second letter followed in March 2008 highlighting the need for all centres offer-
ing neurological and posterior eye surgery to urgently review their progress on the
implementation of NICE IPG 196 (2006) guidance. This letter made reference to
ndings from the NDS pilot studies in relation to how NICE recommendations were
being implemented. It expressed concerns about instrument movement (migra-
tion) between instrument sets, and about the need to reduce the use of supple-
mentary instruments which cannot adequately be tracked. The letter also stressed
the need for centres to procure new instruments for exclusive use in surgery on
children born after 1 January 1997 and identifed key implementation steps.
13
1.1.4 Independent guidance
Independent guidance from NICE, ACDP-TSE RM and ACDST has helped to shape
the NDS 2008/10.
NICE is an independent organisation responsible for providing national guidance
on health promotion and on the prevention and treatment of ill-health. It produces
guidance in three main areas: public health, health technologies and clinical prac-
tice.
In November 2006, NICE issued full guidance to the NHS in England, Scotland,
Wales and Northern Ireland on patient safety and reducing the risk of transmit-
ting CJD via interventional procedures (NICE IPG 196). This guidance is referred
to in the CMO letters cited above. The purpose of this guidance was to further
reduce the theoretical risk of iatrogenic spread of CJD via surgical instruments and
neuroendoscopes. The recommendations relate to those instruments which have
or may have come into contact with high-risk tissues that is, those beneath the
dural membrane (intradural operations), on the retina of the eye and on the optic
nerve. These tissues are classifed thus as a refection of the distribution of vCJD
infectivity within the bodys tissues, should such infection be present.
Note
Within this report reference is made to both CJD and vCJD. Where the term CJD
is used, the intention is to cover sporadic and familial as well as variant disease.
Where vCJD is used, a specic reference to variant disease is being made.
The guidance made specic reference to keeping a separate pool of new neuroen-
doscopes and reusable surgical instruments for high-risk surgery on children born
since 1 January 1997 who have not previously undergone high-risk procedures.
These children are unlikely to have been exposed to Bovine Spongiform Encepha-
lopathy (BSE) in the food chain, or CJD via a blood transfusion.
ACDP is a UK-wide non-departmental public body. Its remit is to advise the Health
and Safety Executive, ministers and the Department of Environment, Food and
Rural Affairs (DEFRA) on all aspects of the hazards and risks to workers and others
from exposure to dangerous pathogens. It is involved in the production of guid-
ance relating to safety at work and the protection of public health, as well as advis-
ing government on the implementation of policy and legislation relating to specic
pathogen risks and their impact.
14
As part of its remit, ACDP-TSE RM produced the guidance document Transmissible
spongiform encephalopathy agents: Safe working and the prevention of infection.
This guidance and the associated annexes aim to minimise the risk of transmis-
sion of CJD and vCJD. It was frst published in June 2003 and has evolved in the
years since, with new annexes being added and current guidance being updated as
further scientic information becomes available or new policy decisions need to be
refected.
ACDST was a DH advisory committee whose purpose was to take forward for po-
tential practical application the body of research relating to the decontamination of
surgical instruments, with the emphasis on protein removal and prion deactivation.
It brought together members of the scientifc, clinical and engineering communities
to focus on the transfer of knowledge from the research environment into practis-
ing surgical instrument reprocessing facilities and services. The committee was dis-
banded at the end of 2010 with the grateful thanks of DH. A new group within the
ACDP structure is in the process of formation and will deal with risk management
in this important area.
In autumn 2006 ESAC-Pr (as it was then called) published a report which provides
background evidence and guidance on changes in surgical instrument provision
and decontamination operations aimed at reducing the possible spread of prion
disease via surgical routes. Its recommendations reinforce the NICE IPG 196 (2006)
guidance.
1.2 Aims and objectives of the NDS 2008/10
The survey is based on the assertion that risk control, based on the use of quality
systems and EN/BSi/ISO standards from existing guidance, together with invest-
ment and development programmes, has raised performance in instrument man-
agement and decontamination to a level such that further risk-reduction strategies,
particularly those related to enhanced instrument quality and reduced prion trans-
mission risk, can now be successfully applied.
The survey aims to assess the progress of measures put forward by DH, NICE and
ACDP-TSE RM to suppress actively the risk of prion transmission, in terms of both
guidance implementation and further development.
15
The aims and objectives of the NDS 2008/10 were:
a. To capture information relating to quality systems for medical device and
surgical instrument reprocessing;
b. To start investigating the discouraged reuse of single-use instruments and
neuroendoscopes, by examining the nature of the migration of surgical in-
struments throughout or into the decontamination lifecycle;
c. To encourage rapid implementation of NICE IPG 196 (2006) guidance;
d. To specifcally examine the implementation of NICE IPG 196 (2006) within
the specialist centres surveyed.
16
2.0 Methodology
The NDS 200810 was carried out in accordance with DH scientifc rules, and
focused on a sample of 30 centres providing high-risk tissue procedures in neu-
rological and posterior ophthalmic surgery in England. The appropriate learned
and professional bodies advised on the sample selection process, with the aim of
capturing a large proportion of those centres making substantial contributions to
surgery in the high-risk tissue areas. Participation in the survey was voluntary and
not performance-related. Only one centre declined the invitation. The subsequent
guidance development pilots have operated at three of the 30 centres mentioned.
Note:
In the performance of this survey some 30 active sites performing neurosur-
gery and/or associated decontamination procedures were visited. However, this
equates to only 28 complete operational units, owing to a combination of trust
mergers and the use by more than one trust of a single decontamination facility.
Care was taken to include all of the current arrangements for decontamination ser-
vice provision. In addition, the special considerations given in NICE IPG 196 (2006)
guidance to surgery on young children are reected in the inclusion of specialist
childrens centres within the survey.
The survey was conducted via a questionnaire which was devised to gather obser-
vational data and keep an objective record of the 30 centres policies and opera-
tional practices as they apply to standards-based quality systems for medical devic-
es and surgical instrument reprocessing. In addition, the survey results are helping
DH to start evaluation of the rate of reuse of single-use instruments and neuroen-
doscopes as well as the nature of migration of surgical instruments between their
parent sets throughout the use / decontamination cycle.
Research took place in the SSDs and operating theatres, with the data collected by
joint research teams comprising independent reseachers, assisted by local staff. The
analysis was conducted by a joint DH / HPA team primarily using a fgure-of-merit
(%) grading system applied to a relational database holding the survey results in
anonymous form.
17
2.1 Scope
The development of the questionnaire and the analysis of the fndings are both
aligned to a risk-reduction philosophy. The questionnaire was developed with
advice from learned and professional bodies. The 30 healthcare service providers
(mostly NHS trusts) who took part in the survey formed a clear majority sample of
the surgical centres performing high-risk tissue surgery and their decontamination
service providers, including those providing paediatric surgical services.
The survey is not intended to be a comprehensive review of decontamination
across the NHS. Instead, it covers many aspects of surgical instrument provision,
use and decontamination, including work taking place in operating theatres or pro-
vided by support services primarily NHS or commercial sterile service units. The
new large centres formed as a result of the National Decontamination Programme
are represented within the survey.
2.2 Questionnaire development
The survey was undertaken using a modern balanced questionnaire, and the data
collected in an MS Access database. A total of 1010 questions were developed,
grouped to take account of the decontamination lifecycle, decontamination quality
systems, NICE guidance and advisory committee recommendations. Whilst the ma-
jority of questions required a binary yes/no answer, some required a value judge-
ment answer. Hidden safeguards were also included, for example, through the
duplication of questions. Several questions in each category were asked a number
of times, but phrased in a different way. Some questions link directly to EN stand-
ards, which themselves inter-relate.
The questionnaire was initially designed to support the survey process, based as it
was on visits and observation. The structure of the survey was then reviewed by a
sub-group of the ESAC-Pr committee and the questions subsequently regrouped
into Quality System Categories for simple comparative analysis.
2.2.1 Survey data questions
Twelve core analysis questions were developed with advice from ESAC-Pr, ACDP-
TSE RM, committee chairs and experts from a range of learned and professional
bodies, to help interpret the survey data. These questions seek to answer whether
18
the investment and development programmes run to date, together with DH guid-
ance and the applications of measures recommended by DH, NICE and ACDP-TSE
RM, have raised performance in instrument management and decontamination,
giving at least some reduction in prion transmission risks.
The 12 questions are:
1. Has NICE IPG 196 (November 2006) guidance to reduce the risk of transmitting CJD
and vCJD been efectively implemented across the 30 specialised centres surveyed?
2. Have the selected centres specifcally implemented NICE guidance and CMO requirements
to reduce the use of supplementary instruments?
3. Have the special measures published by ACDP-TSE RM, designed to reduce risk from per-
sons likely to be a source of CJD and vCJD, been implemented across the specialised centres?
4. Are the centres quality assurance systems (engineering standards) adequate to permit further
developments in risk reduction?
5. Where high quality systems implementation standards are observed, do they extend beyond
the mainstream SSD to the operating theatre and on to other less prominent areas of surgical
service delivered within the institution?
6. Can the centres respond and adapt to changes in national policy, guidance and European
Norms (ENs) which afect surgical instrument decontamination?
7. Steam sterilization is currently the main method by which sterility and prion deactiva-
tion are achieved; Are ENs for this area efectively implemented? Have guidance measures to
improve this area been efectively implemented?
8. Are standards of validation, testing and record keeping in SSDs adequate to support robust
audit and provide a platform for further development?
9. Have centres that ofer paediatric services put safeguards in place to minimise the risk of
young patients presenting for surgery being exposed to the CJD or vCJD infective agent, par-
ticularly for those born since January 1997?
10. As efectiveness of steam sterilization is dependent upon the cleanliness of the instruments
prior to sterilization, have cleaning practices been efectively implemented?
11. Is the physical working environment within SSDs adequate to support long-term improve-
ments to their services?
12. Are staf involved in decontamination appropriately trained?
19
2.3 Research teams
The on-site survey was carried out by teams of four researchers comprising inde-
pendent researchers, with sterile services / engineering and clinical backgrounds,
plus one additional researcher with infection control experience contributed by HPA
as an independent observer of the survey process.
Research participants from the centres were seen as an integral part of the team,
as the survey process owners, and their contribution ensured the seamless conduct
of the on-site survey. Steps were taken to ensure that staff from SSDs, theatre and
engineering disciplines were available to participate on the scheduled survey date.
2.4 Data collation
The research teams collated the data using MS Excel or Access, and transmitted it
securely to a central point. The results were then imported into a Master MS Access
fully relational database so that analyses could be carried out and reports gener-
ated.
2.5 Figure-of-merit (FOM) analysis
The analytical scoring system was based on a FOM approach. A FOM is a quantity
used to characterise the performance of a device, system or method relative to its
alternatives. The main advantage of this technique is that it is able to refect not
only the relative importance of applied methods in this case, the decontamination
processes undertaken by trusts and/or their suppliers but also allows emphasis of
key steps in the decontamination process.
FOM analysis requires the use of weighting factors to establish the relative im-
portance of each item under review, in this instance in risk-reduction terms. DH
assigned each survey question to the appropriate risk-reduction Quality System
Category, based on EN standards. A special sub-group of ESAC-Pr weighted each
of these Quality System Categories on a scale of 1 to 5, according to their relative
importance in terms of protein removal and / or prion deactivation value.
The FOM (%) Score and FOM Rating are two key outputs from the FOM scoring
system.
20
The FOM (%) Score provides a measure of the merit or beneft suggested by each
survey answer. A score of 100% for a specifc answer indicates that the maximum
merit (or beneft) was achieved for that answer. However, it is not possible for a
centre to score 100% over a complete survey, due to the way the questionnaire
is structured. A score of 87% should be considered as approaching the maximum
possible at the time of the 2008 survey visits. As the guidance is revised and this
survey repeated it will become possible for centres to approach a 100% score. This
analytical strategy leaves room for future improvement and provides for the in-
creased risk reduction effect of future guidance.
The FOM Rating grades each FOM (%) Score using an A to E scale, intended to
assist with the interpretation and comparison of the survey results. As discussed
above, an A rating could not be achieved in the initial survey but should become
possible after the introduction of new technologies.
Table 1 illustrates how the FOM Rating is derived from the FOM % Score. The
detail and calculation of the FOM (%) Score can be seen in Annex 1.
Table 1. FOM Rating
FOM (%) Score FOM Rating
88 or above A
7287 B
6071 C
49 59 D
Below 49 E
The survey data are anonymised in any output reports so that the individual trusts
and private service providers are not identifed. The trusts involved have been pro-
vided with a copy of their own report, which includes an explanatory note outlining
the presentation of results and the FOM % Score.
2.5.1 Quality System Categories
DH, with the assistance of ESAC-Pr, agreed a set of Quality System Categories to
facilitate analysis of the survey results, and assigned each survey question to an ap-
propriate category. This approach, in effect, groups the EN, ISO and BSi standards
21
in operational terms (see section 2.2), and provides a platform for prion transmis-
sion risk reduction (see Annex 1).
Weighting factors are scaled from 1 to 5. A weighting of 1 indicates that a survey
question is of minimal relevance in terms of prion removal and deactivation. A
weighting of 5 indicates that the question is of the highest relevance in terms of
prion removal and deactivation. The surveys weighting factors are illustrated in
Table 2.
Table 2. Quality System Categories relevant to prion removal and deactivation
Quality Sys-
tem Category
Relevant guidance Relevant EN/ISO
standards
Weighting
factor
Washing/
disinfection HTMs 2030
Washer-disinfectors:
BS EN ISO 15883
1/2/3
5
Water quality
HTM 04-01
Water supply:
BS 6700
3
Inspection HTM 01-01 Part A 5
Sterilization/
steam
HTM 2010;
HTM 2031;
Steam sterilizers:
BS EN 285 (Large)
BS 13060 (Small)
BS EN 556 1/2
5
Record keep-
ing
HTM 01-01 Part A;
Record Management Code of
Practice (2006)
Medical devices, qual-
ity management sys-
tems: BS EN ISO 13485
5
Instrument
tracking
HTM 01-01 Part A;
GS1 Coding For Success (2007)
5
Instrument
quality control
ESAC-Pr 2006;
MDD Essential Requirements
Medical devices, qual-
ity management sys-
tems: BS EN ISO 13485
2
Stafng/
training
Institute for Decontamination
Sciences (IDSc) initiative;
IHEEM Authorising Engineer
(Decontamination)/AE(D)
5
Management
controls
HTM 01-01 Part A;
CQC;
MHRA notifed body
Medical devices,
quality management
systems:
BS EN ISO 13485
5
22
Quality Sys-
tem Category
Relevant guidance Relevant EN/ISO
standards
Weighting
factor
Dispatch and
transport
Clinical waste:
UN 3291 (see Safe transport
of healthcare waste)
Trade Barrier Regulations (TBR)
(2007)
2
Table 3. Quality System Categories relevant to the quality of decontamination for
general patient and staff safety purposes
Quality System
Category
Relevant Guidance
Relevant EN/ISO
Standards
Weighting
Factor
Environmental
control
HBN 13
BS EN ISO 14644
BS 5925
1
Stafng control HTM 01-01 Part A 1
Personal hy-
giene
Healthcare Associated Infections
(HCAI) Code of Practice (2008)
1
Personnel/ staff
safety
Health and Safety at Work Act
1974
1
Packaging HTM 01-01 Part A; BS EN ISO 11607 1
Microbiological
supervision
HTM 01-01 Part A;
Healthcare Associated Infections
(HCAI) Code of Practice (2008)
1
Disposal HTM 01-01 Part A 1
Survey questions with a weighting of 1 are considered non-relevant Quality
System Categories in prion risk-reduction terms. They therefore fall into the gen-
eral body of measures concerned with obtaining a clean, sterile instrument product
following decontamination. These questions are not included in the trust reports
(Table 3) but do provide a platform for general improvement and modernisation in
decontamination services. They have therefore been included in the analysis.
23
2.6 Statistical reliability data acquisition and
database quality
The validity of any survey is dependent upon the reliability of the data collected.
For this survey the large volume of data collected on each centre does increase the
risk of sundry error. The reliability of the data has therefore been assessed using
two approaches: data type enforcement and inverted logical questions. Data type
enforcement checks that the right type of answer is assigned to the right type of
question for example, yes/no to a logical or binary question. Inverted logical
questions act as a check, in that the correct or positive-scoring answer is a no.
Samples of fve selected questions were examined. Out of those fve, one ques-
tion elicited a single positive response for the majority of supplementary questions,
when the original response was either no or not applicable. It is not possible to
determine which of these represents an error.
Additional recoding rules have been necessary to remove the vast majority of
problems that were caused by an initial lack of data type enforcement prior to the
construction of the present database. It is diffcult to quantify the errors now re-
maining in the database, but these are estimated to be in the order of less than 1%
of the entries, which is unlikely to introduce any major issues concerning the overall
reliability of the results.
2.7 Scope of the data
All 30 of the centres that agreed to take part in the survey completed it. All of the
data collected during the NDS 2008/10 were included in the scoring process, ex-
cept for the following:
Answers to questions with an FOM weighting of 1 have not been scored and are
excluded from trust reports related to prion transmission risk.
DH considers all survey questions assigned a Quality System Category weighting of
1 to be of minimal relevance in terms of prion removal and deactivation. Their ex-
clusion does not affect the scores achieved. However, many of these considerations
are of key concern in the conventional business of cleaning and sterilization. To this
end, three broad analysis questions related to cleaning practices, staff training and
working environment have been included in this report and were analysed in detail
for each individual trust. These analyses were sent to each participating trust on a
confdential basis, the reports covering the work of that centre only.
The details of the FOM scoring and analysis can be found in Annex 1.
24
2.8 Data conversion and impartiality
In some cases, researchers recorded a binary yes/no answer against a numerical
question, or a numerical answer against a binary question. A conversion process
was therefore required for a total 1506 answers or instances, a small proportion of
the total. DH devised the decision tables to determine the appropriate method of
conversion for each possible case. The amended answers are recorded in Annex 1.
25
3.0 Findings
The FOM percentage scores and rankings for the centres surveyed are presented in
Table 4.
Out of the 30 centres surveyed, 19 achieved a rating of B, 10 achieved a rating of
C and 1 an E rating, as outlined in Table 4 and further discussed below. The E-rated
centre has subsequently closed and has been replaced by a modern facility.
Note
As the number of centres visited within the survey is approximately 30, then for
general purposes the resolution of survey results is 3% of the total. However,
because some centres use more than one decontamination service the denition
of a single instance in the survey is variable. On this basis the maximum number
of centres would be 34. In addition, many of the results presented in this survey
report are multi-factorial, bringing together the outcomes from several questions.
It is for this reason that results quoted in the text do always follow the 3% reso-
lution which might otherwise be expected.
When considering these results, it is important to remember that the scoring sys-
tem is designed to take account of the maximum attainment achievable when the
new CFPP 01-01 guidance is implemented in high performing centres. At the time
of the survey, many of the CFPP recommendations were not available, which limits
the maximum possible score; a score of 87% should therefore be considered as ap-
proaching the maximum possible at the time of the survey (see section 2.5).
The large proportion of trusts and decontamination providers gaining scores in the
upper categories is indicative of a national trend toward satisfactory implementa-
tion of the quality systems and other supplementary material covered in HTMs
2010 and 2030 as well as the decontamination manual.
DH sees the above as providing a sound basis for the development of additional
risk control measures within a choice framework, as implemented by CFPP 01-01.
The use of a choice framework reects a mature decontamination environment
which is capable of the decision making and further development required.
Corrected for a maximum attainable score of 87, the lowest score seen (excluding
the one centre which subsequently closed) was 69% of the attainable maximum.
This suggests that even the poorest centre has by the measurements provided in
this survey performed well.
26
Table 4. Overall FOM (%) score and FOM ranking by site (normalised)
Site number FOM (%) score FOM rating
01 81.2% B
02 81.0% B
03 80.2% B
04 79.4% B
05 79.0% B
06 78.3% B
07 77.9% B
08 77.7% B
09 76.8% B
10 76.4% B
11 76.3% B
12 75.6% B
13 74.8% B
14 74.7% B
15 74.3% B
16 74.3% B
17 74.2% B
18 73.6% B
19 73.2% B
20 71.6% C
21 70.1% C
22 69.9% C
23 69.2% C
24 69.0% C
25 68.3% C
26 63.9% C
27 63.5% C
28 62.2% C
29 61.4% C
30 47.4% E*
* centre subsequently closed
27
3.1 Survey data analysis and main ndings
For the sake of clarity, the survey data questions and analysis are listed in their
original numerological order.
1. Has NICE IPG 196 (November 2006) guidance to reduce the risk of transmitting CJD
and vCJD been efectively implemented across the 30 specialised centres surveyed?
NICE IPG 196 (2006) guidance identifes the steps that should be taken to reduce
the risk of transmitting CJD and vCJD via surgical procedures on high-risk tissues
those beneath the dural membrane, on the retina of the eye and on the optic
nerve. These steps include maintaining instruments within their sets (which extends
to supplementary instruments), using rigid autoclavable neuroendoscopes and
single-use accessories, and using separate pools of instruments for children born
after 1 January 1997.
Instrument leakage
The estimated rate of leakage of surgical instruments between sets, particularly in
respect of high-risk tissue contact, is 23.7% (that is, more than one in four instru-
ments migrates into a different set) across the reported survey as a whole. Howev-
er, caution is needed as this degree of migration may occur in a sample taken across
a number of surgical procedures and associated decontaminations. The fgures
should not therefore be interpreted as 23.7% per cycle of use and decontamina-
tion. Subsequent work within the pilots has however confrmed that over a number
of procedures, a quarter of instruments do indeed migrate, though it is important
to understand that the use of supplementary instruments is included within this
overall fgure.
The data identifes that the risk of mixing instruments between sets is greater dur-
ing reprocessing (10.3%) than when in use (4%). Subsequent investigation led by
the pilot site at Newcastle has demonstrated that the bulk of this migration relates
to supplementary instruments. The migration has two components: frstly the
movements between sets of the supplementary instruments themselves and sec-
ondly the mis-identifcation of these instruments, meaning that other instruments
are wrongly moved between sets. On return from reprocessing, 41% of sets have
at least one defective or missing instrument, and this has serious implications for
maintaining the integrity of the set. In general, 34% of migration of instruments
can be detected using the present routine audit and inspection processes.
28
Record keeping and tracking
All centres (100%) have an IT-based instrument set track-and-trace system in use,
as outlined in Health Service Circular 2000/032, and 47% of them are able to track
at least some reusable single instruments. GS1 coding or a comparable system has
been implemented in 35% of centres and 57% keep a record of their instruments
usage for both neurological and posterior eye procedures, and so are able to track
their history at least at the set level. In relation to individual instrument marking,
17% of surveyed centres have uniquely identifed single-use instruments using
techniques similar to those described in DH Coding for Success, which implies the
use of the GS1 scheme. However, 32% have a GS1 related policy in place. It should
be noted that the timing of the survey was such that the Coding for Success pub-
lication may not have been accessible to all of the departments visited.
Where small or benchtop vacuum and air displacement steam sterilizers are used,
traceability of sterilized instruments and devices is shown to be inadequate: those
centres using vacuum sterilizers scored 0% for single instrument tracking and those
with air displacement scored 17%. However, these devices are retained for contin-
gency purposes and are little used in routine decontamination.
Instrument streaming
Steps are being taken to ensure that instruments which come into contact with
high-risk tissues are separated into a discrete administrative stream and kept iso-
lated to prevent any possible mixing with instruments used for other tissues. This
does not imply the use of dedicated plant and equipment for their reprocessing,
though this is feasible in some large centres. The survey shows that 41% of cen-
tres have the capacity to twin-stream their decontamination functions in this way
using administrative measures. Three centres use administrative streaming for other
applications including the protection of sets used for special purposes such as some
areas of ENT surgery. In 32% of centres, administrative instrument streaming has
been introduced to separate high-risk from general acute surgical instruments.
70% of instruments are recorded as being kept in sets during use and whilst be-
ing processed. However, centres experience diffculty in maintaining complete sets
when instruments are taken away for repair. The survey identifes ambiguous prac-
tice in this area, with 28% of centres appearing to suspend the use of a set when
instruments are sent for repair or cannot be traced. However, the data also suggests
that 96% of centres continue to use incomplete sets when necessity demands.
29
Practice regarding replacement instruments also varies: 65% of centres replenish
the set from stocked instruments where these types are also used in general acute
surgery; following repair, 59% return the instrument to the tray from which it was
removed. The remainder place it back into general acute surgery pool. This lat-
ter practice presents an additional risk of prion transmission, and has been advised
against. CFPP 01-01 Part A offers new guidance in this area.
Neuroendoscopes
NICE guidance on neuroendoscopes is adhered to in 72% of centres, which use rig-
id autoclavable neuroendoscopes whenever possible. All accessories used through
neuroendoscopes should be single-use and 64% achieve this aim. These relatively
good results are helped by clinical practice trends, which favour rigid endoscope
use.
Single-use instruments
While NICE did describe but not specifcally recommend the single-use option, all
centres (100%) have a policy in place that permits application of single-use instru-
ments where clinically appropriate. In addition, 37% of these regularly audit and
document in order to reduce the risk of unintended reuse of single-use instruments.
However 3.3% (one centre) reuse single-use supplementary instruments.
This fnding, although related to only a single centre, is evidenced as part of a larger
picture by correspondence to DH. In light of this interest and the legal status of
reprocessed single-use instruments, DH will review its policies in consultation with
MHRA. This does not, however, imply a relaxation of the current position in which
the DH considers those carrying out reprocessing as in effect becoming the manu-
facturer of the reprocessed instrument.
2. Have the 30 selected centres implemented NICE guidance and CMO requirements to reduce
the use of supplementary instruments?
The 2008 survey visits show progress overall, in that 32% of neurological and
posterior eye surgery centres have implemented the guidance relating to supple-
mentary sets in policy, this includes those using the strategy proposed by Newcas-
tle. Some centres (48%) have implemented the guidance partly by using single-use
30
instruments as part of their approach. NICE did not specifcally recommend this
option.
However, if it is accepted that the Sheffeld University risk study which underpins
the NICE guidance essentially demonstrates that there is a relationship between set
integrity (or the avoidance of leakage of instruments between sets) and the risk of
downstream transmission of vCJD and possibly other prion diseases, then the New-
castle scheme offers much. The recorded instances of instrument leakage, including
the use of supplementary instruments, in the subsequent pilot study commissioned
by DH show that the reduction in leakage attained is diffcult to equal by the use of
the single instrument tracking to which NICE did specifcally refer.
Where supplementary instruments are used, 83% of the centres surveyed report
that they are dedicated to central nervous system (CNS) surgery though this in-
cludes the spine as well as the high-risk tissues of the brain. Of the remaining cen-
tres (17%) using supplementary instruments from other specialities, 67% use ENT,
50% use gastro-intestinal, 44% use general, 68% use maxillo-facial, and 64% use
spinal. Only 11% use supplementary instruments from ophthalmic, including pos-
terior ophthalmic. A small number of centres use supplementary instruments also
used in orthopaedics, paediatric, thoracic, cardiac, transplant, vascular, obstetrics,
dental, genitourinary and gynaecology.
Note
The above issue was addressed in a letter from CMO to all relevant providers
which drew attention to the substantial importance of ensuring that supplementa-
ry instruments are not used in surgery to high vCJD transmission risk tissues. DH
has investigated this issue further through a pilot study with Newcastle Teaching
Hospitals NHST. In this study, the prevalence of supplementary instrument use
was investigated within neurosurgery specically. At the outset it found that the
rate of supplementary instrument use was substantial, with virtually all proce-
dures being affected.
DHs protocol called for the use of single instrument tracking as a device to moni-
tor and counter this potential source of signicant risk. However, after early in-
vestigation the Newcastle trust elected to pursue an alternative approach in which
the contents of each neurosurgical set were compared to the clinical need. This
showed that surgeons were not using a proportion of each sets contents, whilst
other supplementary instruments were routinely required. In addition, the sets
could not always be quickly and easily identied, particularly within the operating
theatre.
31
The project then progressed to a thorough investigation of set contents, result-
ing in a review and a move to new set structures carefully matched to the needs
of the surgeon. The sets are colour-coded to make identication easy at all times
and are also somewhat larger than a conventional set in the same clinical area.
The larger nature of the new sets means that some are split into several trays in
order to make handling easier.
The rate of supplementary instrument use within neurosurgery at Newcastle has
subsequently fallen to negligible levels.
3. Have the special measures published by ACDP-TSE RM, designed to reduce the risk from
known or suspected CJD and vCJD carriers, been implemented across the specialised centres?
The survey showed that 93% of centres with specialist interest in neurosurgery
and/or posterior ophthalmics have protocols in place for risk control when working
with patients at increased risk of vCJD owing to large numbers of blood transfu-
sions, tissue transplants, etc. Of these, 54% centre the protocol on an admissions
questionnaire which is applied across all high-risk tissue surgery. Other centres use
questionnaires which are routinely related to inpatient care. The full use of ACDP-
TSE RM guidance Annex J is in place at 68% of centres.
Guidance on the use of neuroendoscopes with respect to at-increased-risk patients
has been introduced in 64% of centres. 93% of centres take an approach which is
clearly recognisable as being related to the ACDP-TSE RM. Of these centres, 38%
kept neuroendoscopes used on at-risk patient exclusively for reuse on that patient.
The survey data does not permit easy identication of the neuroendoscopes against
the technical procedures in which they are used. The evidence suggests that rigid
neuroendoscopes are being reprocessed by conventional steam sterilization where
appropriate.
The implementation of ACDP-TSE guidance has been looked at by a number of
bodies with varying results. A recounting process on this survey showed that at
initial contact many of the centres involved were not able to respond to questions
on ACDP-TSE RM guidance at approximately half the centres visited the survey
team had difculty in identifying the responsible person in respect of this form of
risk control. However, by the latter stages of the survey visits, responsible offcers
had often been located and in consequence reliable results obtained.
CFPP 01-01 therefore addresses this matter with specifc advice on relevant duties.
32
4. Are the 30 centres quality assurance systems adequate to permit further developments in risk
reduction?
Independently-assessed quality systems are in place in 77% of centres. Over 85%
of centres show fully satisfactory records on decontamination equipment validation
and maintenance. The use of EN standards and Quality Systems is clearly evidenced
in 82% of the institutions visited. The majority of these specialised centres are
therefore well placed to build upon current quality controls in the implementation
of new instrument management and decontamination approaches. This additional
guidance relates to the management of surgical instruments at every stage in their
use, transportation, decontamination and storage. The common elements across
these functions, such as record keeping and the need for trained/skilled operators
are particularly emphasised. This is broadly an encouraging result, though there is
an implication that just under a quarter of centres still have substantial work to do if
they are to meet the requirements of CFPP 01-01.
5. Where high quality systems implementation standards are observed, do they extend beyond
the mainstream SSD to theatre and to other less prominent areas of surgical service delivered
within the institution?
In the small number of centres that use small or benchtop sterilizers, almost all
quality standards scored 100%. There are procedures in place in 100% of centres
that use small or benchtop sterilizers to ensure that re-commissioning is undertaken
if a review of records from routine monitoring, periodic testing and performance
requalifcation indicates unacceptable deviations from data observed during valida-
tion. There are, however, some differences in standards between vacuum and air
displacement benchtop sterilizers.
Vacuum steam sterilizers
The maintenance scheme, including procedures and records, is reviewed periodical-
ly by a designated authorised person in 100% of centres this includes annual revali-
dation. However, only 50% of them retain maintenance records securely as part of
the quality system records. A higher percentage 75% document the procedure
for maintenance tasks and the frequency at which they are carried out, but this
remains an area for improvement. Another cause for concern is in the calibration
of recording instruments used for the validation and routine testing of sterilizers,
where just 50% of centres state that there is an effective system in place.
33
Air displacement steam sterilizers
In 67% of all centres with an air displacement steam sterilizer, a designated author-
ised person (AP) reviews the maintenance scheme, including procedures and re-
cords. This meets one of the core requirements on this group set out in CFPP 01-01
A. However, all of the centres visited, which use this equipment, have a local policy
in place and carry out annual revalidation.
The same proportion (67%) has a procedure in place to check that the sterilizer is
used only when all specied maintenance tasks have been satisfactorily completed
and recorded.
Other sterilizers: endoscope reprocessors
Other sterilizers are used in 10 centres (12 units) (33% of those visited) for steri-
lizing or reprocessing endoscopes which cannot be decontaminated in a steam
sterilizer.
Only 24% of these centres have been subjected to a formal documented validation
programme in line with HTM 2010. This is not surprising, as these sterilizers were
plasma-augmented chemical sterilizers, rather than the steam sterilizers subject to
the main thrust of HTM 2010. However, 88% of centres did have another formal
documented validation programme, such as a manufacturer-based validation or
certifcation programme.
Monitoring checks are carried out in 93% of centres on annual revalidation. Of
concern is that only 50% of other sterilizers have a maintenance contract. How-
ever, 87% of the surveyed centres state that they plan and perform preventative
maintenance in accordance with documented procedures, while 63% specify and
document both the procedure for each maintenance task and the frequency at
which it is carried out.
Only 31% of centres have procedures in place for recommissioning, should
deviations be found during validation or upon the review of records. In only
44% of centres are commissioning, performance qualifcation, re-commissioning
and performance re-qualifcation assigned to a designated person who has appro-
priate training and experience, and who may be a suitably qualifed test person.
These ndings may reect the lack of personnel trained in this technology outside
34
manufacturer / supplier organisations. The roles, duties and training of those con-
ducting validation and audit are reviewed in part A of the guidance.
Small and benchtop sterilizers: main ndings
Quality systems and standards. In the centres where small or benchtop
sterilizers are used, there continue to be issues with ensuring that uniform
quality systems are in place. This confrms the fndings of other reports, par-
ticularly those from CQC. Despite this, almost all quality standards scored
100%.
Maintenance records. Only 50% of the centres using vacuum sterilizers
retain maintenance records securely as part of their quality systems records.
Only 75% document the procedure for maintenance tasks and the frequen-
cy at which they are carried out. This is an area for concern.
Air displacement sterilizers. In relation to air displacement sterilizers, the
maintenance scheme (including procedures and records) is reviewed periodi-
cally by a designated AP Sterilizers in two-thirds (67%) of all centres with
such equipment.
Small and benchtop sterilizers - validation. While other sterilizers, including
small and benchtop types, are most often not validated in accordance with
HTM 2010, 88% of them did have another formal documented validation.
Small and benchtop sterilizers - recommissioning. Recommissioning of other
small or benchtop sterilizers is often poor, both in terms of procedures and
the availability of appropriately-trained staff to carry out the work.
6. Can the centres respond and adapt to changes in National Policy, guidance and European
Norms which afect surgical instrument decontamination?
The assumption made in this analysis is that those with good standards of quality
system development and guidance compliance have created a strong platform from
which further developments can be made with little risk that the inherent cohesion
of the process will be compromised.
In relation to quality assurance systems, the survey identifed that an independent-
ly-assessed quality system is in place in just over three-quarters (77%) of centres
(see Question 4). Of the remaining 23%, it may be that at least some are proceed-
ing in a satisfactory way using alternative risk control measures but this cannot be
35
confrmed from the available data. However, 93% make use of quality systems
which accord with EN ISO 13485: 2003. Amongst other considerations, the guid-
ance given in CFPP 01-01 is aimed at ensuring that those centres with signifcant
defciencies in their formal QA systems will address the issues and so create a sound
platform for further progress.
Over 93% of centres have a system in place to ensure that medical devices (sur-
gical instruments and endoscopes) and suppliers are reviewed to ensure that the
products used comply with EN and BSi standards.
Quality systems records is deemed reliable where equipment is maintained with
validation records to demonstrate a satisfactory performance. In general, mainte-
nance standards have been good, albeit requiring improvements to documentation
and record keeping.
Validation of washer-disinfectors of all types has been good. 97% maintain vali-
dation reports and records on the calibration of test instruments. Whilst 97% of
centres carry out an annual revalidation on their major systems (see Question 7),
arrangements for recommissioning are sometimes poor, with just 55% of SSD-
based equipment and 67% of other small or benchtop sterilizers being recommis-
sioned and retested where required as a result of a review of records (see Questions
5 and 8). Only 44% of centres assign revalidation to a designated person with
appropriate qualifcation and experience. These variable results would suggest that
for some centres, improvement is required in quality systems as part of gaining full
advantage from the new guidance.
Local observations reported by 47% of centres visited suggested that the test soils
in use did not represent the surgical soiling seen in terms of diffculty in removal.
Environmental standards provide the basic platform for both quality assurance
procedures and quality systems to develop. Most centres scored 80% or above
on environmental standards, that is, the building design and facilities which sup-
port the decontamination process (see Question 10), although there were areas
for improvement, in particular in the provision of storage for sterile products, ef-
fective ventilation and facilities for the use and maintenance of test equipment.
Beyond this there are signifcant failings in the provision of hand-washing facilities,
particularly in respect of inspection areas where the 01-01 guidance calls for higher
standards, similar to those found on wards. Further development in these areas is
dependent upon addressing the identied shortfalls so that the recommendations
contained in CFPP 01-01 can subsequently be accommodated.
36
Of the centres surveyed 79% have existing arrangements for liaison between de-
contamination and control of infection staff in regard of risk control and the NICE
guidance.
The survey evidence suggests that most centres are now able to implement nation-
al policy, HTM guidance and international standards affecting surgical instrument
decontamination in an effcient manner. However, the challenge is identifed as sig-
nifcantly greater when guidance from bodies such as NICE and advisory commit-
tees - including ACDP TSE WG - is to be implemented for risk reduction purposes.
The proposed introduction of the Surgical Instrument Manager role and the move
from the HTM structure to the new CFPP is intended to support both commission-
ers and care providers in the adoption of this additional tier of recommendations.
The CFPP guides commissioners, quality inspectorates and service providers in a
fashion which offers choice and permits those with a strong basic quality system to
take full advantage of this attribute.
7. Steam sterilization is currently the main method by which sterility and prion deactivation
are achieved:
Are ENs for this area efectively implemented? Have guidance measures to improve this area
been efectively implemented?
Steam sterilization is essentially based on parametric discharge, that is steriliza-
tion of instruments may be assumed provided the recommended temperatures,
pressures and durations, etc, have been attained during the process. Much of this
depends on the sterilizer being well-maintained and validated. Validation in this
context is applied to the sterilizer cycles actually used in the local centre concerned
and demonstrates, to the satisfaction of an independent AE (D), that the machine is
attaining the required values for each of the parameters discussed.
Maintenance of equipment in SSD
The great majority of SSD centres (92%) have a service level agreement in place
for the maintenance of steam sterilizers. In addition 88% keep documented proce-
dures for each maintenance task and for its frequency. Of these, 97% retain main-
tenance records securely as quality records and have a procedure in place to ensure
that the maintenance scheme is reviewed periodically by a designated AP Steriliz-
ers, as recommended in the existing guidance. The maintenance scheme, including
procedures and records, is reviewed periodically by a designated person in 88% of
37
centres. These fndings demonstrate that a very high standard of maintenance is
being achieved.
Maintenance of small or benchtop sterilizers
Responsibility for the maintenance of small or benchtop vacuum and air displace-
ment sterilizers is assigned to suitably qualifed personnel in all (100%) centres (see
Question 5) where this equipment is used. All of those centres using air displace-
ment small or benchtop sterilizers retain maintenance records securely as part of the
quality system, while only 67% document the procedure for maintenance tasks and
the frequency at which they are carried out. Related to this 67% of centres have
procedures in place to ensure that a sterilizer is not used until any required mainte-
nance and revalidation is conducted. This demonstrates limitations in the manage-
ment of the equipment and illustrates the need for further guidance in this area to
ensure vigorous implementation of the quality system.
Validation
Almost all the centres (97%) assign periodic testing, maintenance and validation
to a qualifed test or maintenance person. However, only 77% fully document
their validation procedures, recording details of the tests and checks to be carried
out and the frequency with which they should be and are performed. While 97%
of all centres carry out an annual revalidation, what constitutes validation varies
across the centres. For example, about 3% (one centre) do not carry out an auto-
matic control test or a thermometric test for small and large loads on revalidation,
while only 72% have an effective system in place for calibrating the indicating and
recording instruments used to validate and routinely test sterilizers. This is an im-
portant area for potential further risk reduction and is emphasised in the new CFPP
guidance. The new guidance offers choice as to the method used to support the
validation process but strongly emphasises and denes the key elements within
validation. Working with the Institute of Decontamination Sciences (IDSc), DH has
also more clearly allocated the roles of persons/staff within the overall process of
maintenance, periodic testing and formal validation.
At the time of the initial survey, guidance in this area was provided by HTM 2010
and the Medicines and Healthcare products Regulatory Agency (MHRA) guidance
in relation to benchtop sterilizers. The need to develop guidance further was a mo-
tivating factor for the generation of CFPP 01-01.
38
8. Are standards of validation, testing and record keeping in SSDs adequate to support robust
audit and provide a platform for further development?
Porous load sterilizers
The analysis has already established that the majority of centres (97%) carry out an
annual revalidation exercise, and that they assign periodic testing, maintenance and
validation to a qualifed test or maintenance person. The responsibility for deter-
mining the necessity and extent of repeating elements of performance validation
is assigned to a designated person with appropriate training and qualifcations in
82% of centres. For all of the centres this work is assigned, including performance
requalifcation, to a suitably qualifed test person.
These fndings are in keeping with the validation fgures in Question 7, where 97%
of centres have a qualifed test or maintenance person assigned to periodic testing,
maintenance and validation. It would appear that the repeating elements of ongo-
ing performance validation processes are almost always assigned to a designated
person with appropriate training and qualifcations.
Where a review of records from routine monitoring, periodic testing and perfor-
mance requalifcation indicates the need for recommissioning, only 55% of centres
subsequently carry out this action. Of the centres surveyed, only 44% were cor-
rectly assigning revalidation to a designated person with appropriate qualifcation
and experience. These fndings demonstrate a need for further guidance on roles
and responsibilities.
The correct calibration of instruments used in the testing and validation of steam
sterilization equipment is a key issue. Incorrectly calibrated instrumentation may
result in errors in the validation of sterilizers, compromising the validity of the whole
process. Accordingly, the use of a systems approach to calibration is recommended
in the extant guidance, though this predates recent refnements. When these re-
fnements are taken into account, 72% of centres would still be classifed as having
an acceptable approach. In order to build on this position, systems for validation
instrument calibration are described and strengthened in CFPP 01-01 B.
39
Washer-disinfectors
In almost all centres (97%), the person carrying out the yearly revalidation tests is a
qualifed test person (AP Sterilizers), with suffcient relevant experience and appro-
priate training to enable him or her to maintain and test washer-disinfectors. That
same person carries out the yearly revalidation tests to a satisfactory standard and
reviews the maintenance records and log books to ensure that they are satisfactory.
There were revalidation reports, documenting the test instrumentation used and
a calibration certifcate traceable to national standards, in 94% of centres. In each
case the test instrumentation had a current calibration certicate at the time of
washer-disinfector revalidation. It would appear that the results for washer-disin-
fectors are slightly better than those for sterilizers. CFPP 01-01 recommends that
the results from this work be reported to the Head of Decontamination and to the
proposed new role of Surgical Instruments Manager.
Note
These ndings suggest that guidance and audit of validation, testing and record
keeping in SSDs need strengthening. This issue is a focus in the new CFPP 01-01.
Clearer allocation of duties to key members of staff is seen as a way of improving
results in this area.
9. Have centres that ofer paediatric services put safeguards in place to minimise the risk of
young patients presenting for surgery being exposed to the CJD and vCJD infective agent,
particularly those born since January 1997?
Of the centres offering paediatric services, only 26% have a comprehensive strat-
egy in place to adhere to NICE guidance on separate sets of what might be called
high-risk tissue surgery instruments for children born since January 1997;
24% of centres have a strategy for managing a separate pool of neurological in-
struments; 18% have a separate pool of neuroendoscopes; and 36% have a sepa-
rate pool of posterior ophthalmic instruments. In addition, 74% can identify instru-
ment sets used on a non-exclusive basis with children born post-January 1997 and
11% can identify individual instruments used in instrument sets and supplementary
instrument sets. However, no centre outside the pilots is achieving full risk control
with respect to vCJD transmission for children born after January 1997.
Although some pilot centres such as Newcastle Teaching Hospitals NHST and
GOSH have made good progress in this area, the overall results show a need for
40
further guidance on implementing NICE IPG 196 (2006). At present the risk-reduc-
tion targets, set as part of NICE IPG 196 (2006), are not being achieved.
10. As efectiveness of steam sterilization is dependent upon the cleanliness of the instruments
prior to sterilization, have cleaning practices been efectively implemented?
Manual cleaning practices
While automated cleaning methods are preferable to manual cleaning and are
dominant in the acute sector, there are times when manual cleaning is necessary,
either in addition to an automated process or, in exceptional circumstances, when
a piece of equipment cannot be cleaned using an automated process. The survey
shows that 84% of centres have documented criteria for choosing when to under-
take manual washing, 93% have a protocol in place and 97% of staff engaged in
washing and disinfection are specifcally trained in this process.
One or more dedicated sinks for instrument cleaning are available in 84% of cen-
tres. The sinks are included as a positive fnding in this survey report only where
they are properly designed and equipped for instrument washing.
As to whether or not instruments or equipment are cleaned according to current
guidance, just 10% confrm that cleaning is carried out under running water rather
than via immersion, and only 12% have extract ventilation to minimise aerosol
dispersion during the manual cleaning process.
The cleaning process is of particular importance where instruments have lumens,
and therefore an enhanced potential for biomolecular contamination. In these
instances the use of carefully-selected detergents and appropriate equipment is
of particular importance. In 65% of centres, a specialised instrument detergent is
used for additional or specialised cleaning of instruments which have lumens. Of
the centres surveyed, 85% use a soft bristle rather than a potentially damaging
wire brush or pipe cleaner with these instruments. All centres process instruments
with lumens in a washer-disinfector following manual cleaning. No centres use wire
scourers on the outside of instruments, and 24% use nylon scourers.
Of the centres, 80% consistently use the same detergent throughout their
decontamination facilities and 93% of these confrm that the concentration used is
as specied by the manufacturer and the concentration level is measured by pro-
tocol in 86% of cases. However, only 80% of centres have calibrated the volume
41
of water used in their sinks. Where this is done and the protocol is applied to the
volume of detergent used, then a reliable dilution factor will be obtained. Further,
only 40% specify the water temperature for the commencement of manual clean-
ing. The current technologies are validated by a visual instrument inspection pro-
cess and thus are optimised to the appearance of cleanliness.
The planned shift to an emphasis on protein removal and related testing will affect
this area greatly evidence from studies at Porton Down showed no correlation be-
tween the visual appearance of instruments and the extent of protein contamina-
tion. There are also special problems in respect of determining the cleanliness status
of instrument lumens. Here visual inspection is diffcult and at least some of the
new technology tests are unlikely to be effective.
For instruments which cannot be immersed or satisfactorily wetted in a stream of
water because of their design or construction which occurs in 90% of centres
practice is variable. 96% report thoroughly wiping instruments with a clean damp
cloth, and 45% with an alcohol wipe. It is not clear whether the alcohol wipe is in
addition to the wipe with a damp cloth.
Hand-washing
The intention is that a separate basin always be provided for hand washing, but the
surveys environmental fndings (see Question 10) show that only 36% of centres
have dedicated wash-hand basins sited near enough to the dedicated instrument
cleaning sinks that staff can readily wash their hands between and after processes.
Equally, a ftting is only seen as a wash-hand basin when no plug is present and the
taps are capable of elbow/arm/foot or remote operation.
Washer-disinfectors
Data analysis in previous questions has covered maintenance, testing, validation
and record keeping. The focus of this particular question in relation to washer-
disinfectors is on the loading of the surgical instruments. Validation tests are un-
dertaken in 56% of centres to determine the most effective locations for placing
soiled instruments in washer-disinfectors. The purpose of such tests is to improve or
maintain the cleaning process.
42
Drying
While all centres (100%) dry instruments following manual cleaning, the drying
method varies considerably: 63% dry the instruments manually, 53% with a paper
towel, 39% with hot air, 30% with an alcohol wipe and 13% leave them to dry in
the atmosphere. These fgures indicate that some centres use more than one of the
methods listed above.
Inspection of the cleaning process
Daily inspection or review of the cleaning process, including the visual inspection of
instruments, is in place in 70% of centres.
All centres (100%) inspect each instrument following cleaning and in 86% of cases,
inspections are carried out by someone other than the designated person in charge
of cleaning. A record of who washed the instruments is kept at 67% of centres.
Monitoring cleaning efcacy
There appears to be some confusion as to what quantitative and non-quantitative
tests are for cleaning, with 65% of centres stating that they use quantitative or
semi-quantitative test methods, and 57% stating that they use non-quantitative
test methods. It is not possible from these results to determine if any centres do not
use testing methods at all.
65% use quantitative or semi-quantitative test methods
51% use semi-quantitative tests (ninhydrin or biuret)
24% use more nearly quantitative tests (OPA)
81% use weekly residual protein test
57% use non-quantitative methods
Staff training
The survey shows that 82.5% of operator staff are trained and skilled in the tasks
which they are expected to perform. However, some aspects of training are better
43
than others. For example, while 97% of staff who carry out manual washing are
trained in the activity, only 70% have taken part in a training programme leading
to a formal qualifcation.
11. Is the physical working environment within SSDs adequate to support long-term improve-
ments to their services?
DH provides guidance on the working environment in Health Building Note (HBN)
13 and the questions within the survey are largely based on HBN 13 guidance.
Most centres achieved more than 80% for standards related to the SSD environ-
ment, which is a very positive outcome. Where standards are less satisfactory, a
number of themes emerge, including:
a lack of materials stores and ill-used sterile stores;
poor compliance with controlled ventilation standards;
a lack of appropriate wash-hand basins;
a lack of testing and calibration equipment for inspection equipment;
variances in microbiological sampling procedures and documentation; and
a lack of defned procurement polices.
Materials and sterile goods storage
Sterile products should be stored in a suitable environment, preferably a dedicated
store. Even though 76% of centres surveyed have a sterile goods store, they often
use these to store products other than processed goods. For example, 20% use
them for laundered textiles, 40% for detergents and chemicals and 24% for
replacement instruments. This also leaves a number of centres (24%) with no
dedicated sterile products storage area.
In addition, 77% have dedicated materials stores for material used in decontami-
nation and these are equipped with interlocking doors. However, the additional
requirements recommended in HBN 13 are not met by 23% of these storage
facilities.
44
Gowning area
The standard for SSDs is to have a gowning area within the washroom. When
asked if they had a gowning area, only 36% of centres responded positively. This
survey is unable to establish whether the centres have a gowning area or an alter-
native gowning room.
Ventilation
The survey sought to identify the air pressure regimes present in SSDs. A few cen-
tres responded that they had both positive and negative pressure in the same area,
probably refecting the use of a fow-through clean to dirty approach.
Taking account of the above uncertainties the survey shows that only 35% of ster-
ile goods stores have positive air pressure.
Raw materials storage is present in 77% of centres, where a positive pressure re-
gime is applied for goods protection, whilst 31% of centres have negative pressure
storage facilities to restrain fumes and other forms of leakage. The survey shows
that 67% of inspection and preparation for wrapping (IAP) rooms are mechanically
ventilated under reduced pressure. The concern here is that 33% of IAPs are not
mechanically ventilated.
In relation to wash areas, 77% register negative pressure. However, the survey is
unable to establish what the remaining 23% have and can only assume that they
have no mechanical ventilation. Sterilizer loading areas have positive pressure in
33% of centres.
These ndings suggest that there is a need to strengthen and clarify guidance in
this area.
Wash-hand basins
The survey sought to identify whether particular areas of SSDs had wash-hand ba-
sins. The fndings identifed that only 38% of goods reception areas have a wash-
hand basin. Washrooms have wash-hand basins in 36% of centres, but only 76%
of these are compliant with wash-hand basin specifcations.
45
Surgical instrument test equipment including electrical safety
The availability of equipment for testing surgical instruments is poor. Just 26%
of centres surveyed have a diathermy insulation tester, only 50% of which show
evidence of calibration. An electrical continuity tester is available in only 34% of
centres, and of these only 70% show evidence of calibration. Only 57% have a
compressed air source for testing power tools, with only 40% having evidence of
calibration.
These fndings suggest that a marked improvement is required in this area.
Maintenance of inspection equipment could also be improved, with only 53% of
centres having a formal procedure for lighting maintenance and 76% having a
formal procedure for heat sealers maintenance. It may be that the procedures are
in place but are not documented.
Infection control
Environmental microbiological sampling takes place in 74% of centres. However,
only 67% have a procedure in place for dealing with a test failure. There is only
limited guidance within HBN 13, HTM 03-01 or from MHRA for this area. How-
ever, notifed bodies are applying the MDD standard for registered units. This is an
important area for future improvement.
Procurement
Clinical teams, infection control teams and SSD personnel are key to the buying
process. In 73% of centres, a named individual prepares pre-purchase specifcations
and the same number (73%) review them to check that the items are compatible
with existing equipment, processes, cleaning chemicals and procedures. User and
decontamination team liaison particularly designed to ensure that equipment can
be reprocessed is in place in 75% of centres.
Infection control teams are involved in the instrument procurement process in 43%
of centres, and 24% of these also involve an AP. If an item cannot be cleaned,
disinfected or sterilized with existing equipment, 40% of centres have a written
document identifying an alternative process. The availability of decontamination
information prior to purchase is determined by 62% of centres.
46
Signicant improvements need to be made in order to involve all relevant parties in
the purchase of surgical equipment.
12. Are staf involved in decontamination appropriately trained?
The results for staff training give a mixed picture with regard to each specifc area
of decontamination training. The survey identifes that 82.5% of operational staff
are appropriately trained and skilled for the tasks which they are expected to per-
form, and that this training is recorded. Results confrm that for 93% of centres,
there is a procedure in place which ensures that staff undertaking reprocessing are
trained on handling new items. All staff (100%) are trained to ensure that decon-
tamination is carried out to manufacturers instructions, 97% of which is docu-
mented.
A periodic review of skills takes place in 97% of centres, with 93% documenting
the review and any training required. While training is clearly taking place, only
72% of centres have implemented a dedicated training programme. Up to 76% of
centres report quality issues which they consider to be closely related to a require-
ment that staff be trained adequately in the application of quality systems based on
international standards. Staff lack formal qualifcations in much of this area.
47
4.0 Discussion and conclusions
The survey fndings provide a sound baseline for any follow-up research. They can
be used to determine:
Whether standards in decontamination quality systems in high-risk tissue
centres have continued to improve, stayed static or declined compared to a
baseline established in 1999.
How well developed decontamination quality systems are, immediately prior
to the publication but after piloting of CFPP 01-01 Parts A, B, C, D and,
therefore, the ability of the centres in question to implement the detailed
requirements of NICE IPG 196 (2006) guidance.
4.1 The surveyed centres performance
The NDS 2008/10 indicates that the majority of centres are implementing repro-
cessed surgical instrument quality system guidance and that engagement with the
guidance is such that a positive impact on protein removal and prion infectivity
reduction would be expected. Brief experimentation conducted as part of a prelimi-
nary study in advance of a new pilot at Southampton University Hospital has tend-
ed to support this view. When the quality system requirement and manufacturers
instructions were fully and properly applied to specied washer-disinfectors it was
found that for hydrophilic proteins a removal ratio of 104 was obtained. In similar
experiments with hydrophobic examples (fbrinogen) the effects were however less
pronounced, with a removal factor of about 100 being observed.
However, the evidence also suggests that certain aspects of decontamination guid-
ance are better followed than others, and that further development of the guidance
is needed to raise standards in all of the recommended areas.
4.11 Implementation of NICE IPG 196 (2006) guidance
Implementation of NICE IPG 196 (2006) guidance has not progressed as rapidly or
fully as had been expected. It is likely that the potential reduction in prion trans-
mission risk offered by this guidance is not yet being fully realised in hospitals in
England, so that patients remain at a higher risk than necessary of being exposed
48
to the CJD or vCJD infective agent from unsuspected carriers. For many centres,
key measures such as the reduced migration of instruments between sets and the
removal of supplementary instruments are not yet in place. The track-and-trace
technologies which enable single instruments to be tracked are only implemented
and working in a small number of centres. Set-based tracking is, however, almost
universally applied.
The paediatric risk-reduction recommendations in NICE IPG 196 (2006) have been
particularly poorly implemented, despite the emphasis on the importance of these
measures. However, work in the pilot centres supported by DH is leading to a much
better understanding of how to implement the NICE IPG 196 (2006) recommen-
dations; business planning and procurement strategies have been developed, for
example. The pilots have also successfully linked the new instruments for use with
young children to their clinical programmes and to single-instrument tracking. If
copied on a national basis, it is likely that the current poor implementation position
could be rapidly improved.
The letters from CMO in support of NICE IPG 196 (2006) guidance seem to have
had a positive impact on the implementation of the risk-reduction measures.
4.12 Reuse of single-use instruments
The survey shows qualifed evidence that the reuse of single-use instruments does
occur though at a low rate.
4.13 Implementation of ACDP-TSE RM guidance
The guidance from the ACDP-TSE Working Group on control of surgical infection
transmission risk from at-risk patients is reasonably well implemented, although
some of the more specifc recommendations have not yet seen full application.
New guidance from the ophthalmic working group of ACDP-TSE is available as
Annex L from the Advisory Committee website.
4.14 External decontamination services
The survey provides limited evidence, from a small number of neurosurgical
centres where outside commercial contracts are used for decontamination of
49
surgical instruments that such suppliers do not always make distinctions in terms of
the management of instruments which are used with high prion transmission risk
tissues. This leads to diffculties with the implementation of NICE IPG 196 guid-
ance.
Helpfully, the Birmingham Childrens Hospital pilot is being conducted with an ex-
ternal supplier and this company has agreed to assist both the hospital and DH with
a study in this area.
4.15 Adherence to quality standards
The analysis related to decontamination process quality systems, derived from BSi/
EN/ISO quality standards and their implementation, shows strong performance in
this area. The implication is that procedures and controls are suffciently robust in
most centres to permit a round of further improvement and the eventual imple-
mentation of the new anti-prion decontamination technologies reported on in the
ESAC-Pr New Technologies Working Group Report on Prion Inactivating Agents
(August 2008).
4.16 Operational practices
Consistent and well-designed operational practices are a key aspect of decontami-
nation and crucial to maintaining a continuously high quality of product output.
The majority of centres have good controls and practices in place and many show
examples of best practice.
4.17 Safety testing equipment
There are real concerns about instrument and safety device test equipment, used to
ensure that surgical instruments are safe for use, particularly in respect of what may
be severe electrical hazards. The lack of insulation testing equipment for diathermy
is a matter for particular concern, as are a number of other detailed fndings in this
area. The focus of CFPP 01-01 on this safety issue will be improved and a profes-
sional letter to heads of surgical and decontamination departments is recommended.
50
4.18 Environment for decontamination
The environment in which decontamination and instrument management are car-
ried out has not improved as rapidly as the equipment itself. Many centres fail to
provide such simple key facilities as wash-hand basins. Room and space designation
for specifc tasks, particularly those related to storage, is weak. This indicates a need
to modernise the guidance on the decontamination environment. Ventilation of the
environment and rationale for airfow strategy are weak in many centres.
4.19 Training and management
The results on record keeping and staff training imply a good quality workforce
with mostly high standards of management. The work of occupational health and
human resources departments in this area appears to be strong, with evidence of
safe outcomes. However, there is an identifable absence of professional training
and recognition amongst many grades of staff.
4.2 Creating a platform for new technologies
Animal assays based on the use of prion-contaminated wires suggest that the cur-
rent decontamination approach is of limited value in reducing prion risks, particu-
larly where instruments have been in contact with high-risk tissues. However, the
improvements recommended in existing guidance and monitored by the NDS are
intended to create suffcient strength in quality control to make the introduction of
new and potentially more effective decontamination technologies a valid option.
These new technologies are described in an ESAC-Pr document New Technologies
Working Group Report on Prion Inactivating Agents (August 2008).
51
5.0 Recommendations
The imperative today is to build on the sound implementation of existing guidance
towards further improvement in both general and prion infection risk-reduction. To
this end the recommendations are:
a. Strengthening NICE IPG 196 (2006) implementation, using evidence from
the pilot sites (see CFPP 01-01 Part A) to support the provision of further
guidance in CFPP 01-01. FOM analysis confrms the need for a greater
emphasis on implementation of protein removal and prion risk-reduction
features in decontamination;
b. Considering why trusts are not making more progress with implementing
NICE IPG 196 (2006) and other prion risk-reduction guidance, to establish
whether cashow implications or other priorities may be preventing them
from realising the guidance in full. DH has already completed work in this
area, and the cost of implementing guidance in CFPP 01-01 has been fully
researched;
c. Devising an urgent programme of improvements for equipment safety and
calibration testing, with particular emphasis on diathermy;
d. Promoting a stream of further quality systems improvement from the use of
EN, ISO and BSi standards through to CFPP 01-01. The report fndings sup-
port the need for further operational guidance in this area;
e. Consulting with the ACDP-TSE RM sub-group on enhancing the use of its
guidance, now that good data on implementation has been established. The
inclusion of references to ACDP-TSE RM guidance in CFPP 01-01 for gen-
eral and ophthalmic surgery and in CFPP 01-06 for non-sterile endoscopy
was a recommended priority of this report;
f. Optimising the use of washer-disinfectors. The validity of proposals for new
research on protein removal in washing processes is well-supported by cur-
rent quality systems implementation, making washer-disinfectors optimisa-
tion both feasible and worthwhile in the working environment;
g. Introducing interdictive prion control measures, designed to block complete-
ly the transmission of prions, as soon as the scientifc evidence supports their
52
selection and incorporation. Appropriate heed must, however, be paid to
staff and patient safety in the selection of candidate technologies. The need
for care over residual toxicity is mentioned within the guidance;
h. Introducing local self-audit programmes in the centres, particularly in those
where implementation of NICE and ACDP guidance is being pursued. This
programme will be conducted by an independent learned body with DH
support in results analysis;
i. Repeating the survey in two or more years time to examine the effect of
implementing CFPP 01-01 is advised by learned bodies and is under consid-
eration by DH;
j. Developing better guidance on the physical environment for ventilation of
decontamination facilities by the provision of further design guidance;
k. Advocating such simple improvements as the better provision of wash-hand
basins and operational protocols in order to raise hygiene standards in in-
spection rooms within decontamination units;
l. Strengthening surgical instrument management, with the introduction in
CFPP 01-01 of the role of Surgical Instruments Manager within all surgical
centres in acute care, together with better protocols for implementation and
audit. Loan set instruments may also be a factor here and the use of audit
for reliable tracing is recommended. In the case of high-risk procedures a
link to patient identity appears necessary and would t with the position
taken by ACDP-TSE RM. The systems provided by Connecting for Health
and Coding for Success are suitable for this purpose;
m. Introducing measures to reduce the likelihood of single-use instrument
reuse. A need for enhanced guidance on the disposal of single-use instru-
ments is a key issue raised by several groups co-operating in the survey;
n. Reviewing single-instrument tracking and set structure. A series of options
are described fully in CFPP 01-01 A; and
o. Reviewing commercial contract terms to ensure that compliance with cur-
rent decontamination guidance, such as that contained in NICE IPG 196
(2006), CFPP 01-01 and provided by ACDP-TSE RM, is refected in arrange-
ments for external surgical instrument decontamination services.
53
6.0 References
6.1 DH standards, guidance, reports and professional letters
Department of Health (2003) Winning ways: working together to reduce health-
care associated infection in England. Report of the Chief Medical Offcer. DH.
http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/ PublicationsPoli-
cyandGuidance/DH_4064682
Department of Health (2002) Getting ahead of the curve: a strategy for combating
infectious diseases (including other aspects of health protection). DH. http://www.
dh.gov.uk/en/Publicationsandstatistics/Publications/ PublicationsPolicyandGuid-
ance/DH_4007697
Department of Health (2007) Clarifcation and policy summary Decontamination
of reusable medical devices in the primary, secondary and tertiary care sectors (NHS
and Independent providers). DH. http://www.dh.gov.uk/en/Publicationsandstatis-
tics/Publications/ PublicationsPolicyAndGuidance/DH_074722
Department of Health (2009) The Health and Social Care Act 2008: Code of Prac-
tice for the NHS on the prevention and control of healthcare associated infections
and related guidance. DH. http://www.dh.gov.uk/en/Publicationsandstatistics/
Publications/PublicationsPolicyAndGuidance/DH_093762
Department of Health (2007) Decontamination of surgical instruments in light of
National Institute for Health and Clinical Excellence (NICE) Guidance. A profession-
al letter from the Chief Medical Offcer. DH. http://www.dh.gov.uk/en/Publica-
tionsandstatistics/Lettersandcirculars/Professionalletters/Chiefmedicaloffcerletters/
DH_066069
Department of Health (2008) Decontamination of surgical instruments: National
Institute for Health and Clinical Excellence (NICE) guidance: Patient safety and re-
duction of risk of transmission of Creutzfeldt-Jakob Disease (CJD) via interventional
procedures. A professional letter from the Chief Medical Offcer. DH. http://www.
dh.gov.uk/en/Publicationsandstatistics/Lettersandcirculars/Professionalletters/
Chiefmedicaloffcerletters/DH_083298
54
Department of Health (2003) Transmissible spongiform encephalopathy agents:
safe working and the prevention of infection Guidance from the Advisory Com-
mittee on Dangerous Pathogens and the Spongiform Encephalopathy Advisory
Committee. DH.
http://www.dh.gov.uk/ab/ACDP/TSEguidance/index.htm
Department of Health, Engineering and Science Advisory Committee (ESAC-Pr)
(2006) The decontamination of surgical instruments with special attention to the
removal of proteins: and inactivation of any contaminating human prions. A report
by DH ESAC-Pr committee. DH. Available from: http://www.dh.gov.uk/en/Publi-
cationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_072443
Department of Health, Engineering and Science Advisory Committee (ESAC-Pr)
(2008) Report on prion inactivating agents. New Technologies Working Group: DH.
http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPoli-
cyAndGuidance/DH_086805
Department of Health (2006) Standards for better health. DH. Available from:
http://www.dh.gov.uk/en/publicationsandstatistics/publications/publicationspoli-
cyandguidance/dh_4086665
6.2 NICE Guidance
National Institute for Clinical Excellence (2006) Patient safety and reduction of risk
of transmission of Creutzfeldt-Jakob disease (CJD) via interventional procedures.
Guidance developed at the request of the Chief Medical Offcer. NICE. Available
from: http://www.nice.org.uk/page.aspx?o=cjd
6.3 Department of Health Building Notes, Technical Memo-
randa and facilities guidance
Department of Health (2007) HTM 03-01: Heating and ventilation systems: Spe-
cialised ventilation for healthcare premises. Part A Design and validation. https://
publications.spaceforhealth.nhs.uk (log-in required)
Department of Health (2007) HTM 03-01: Heating and ventilation systems: Spe-
cialised ventilation for healthcare premises. Part B Operational management and
55
performance verifcation.
https://publications.spaceforhealth.nhs.uk
NHS Estates (2006) HBN 26: Facilities for surgical procedures: Volume 1. https://
publications.spaceforhealth.nhs.uk
NHS Estates (2004) HBN 13: Sterile services department.
NHS Estates (2002) HFN 30: Infection control in the built environment: design and
planning.
6.4 Medical devices directives and regulations
Statutory Instrument 2002 No. 618: The Medical Devices Regulations 2002. www.
opsi.gov.uk/si/si2002/20020618.htm
European Council Directive 93/42/EEC of 14 June 1993 concern-
ing medical devices. http://eur-lex.europa.eu/LexUriServ/LexUriServ.
do?uri=CELEX:31993L0042:EN:HTML
Medicines and Healthcare products Regulatory Agency (2006) Bulletin No 17:
Medical Devices and Medicinal Products. London: MHRA. http://www.mhra.gov.
uk/Publications/Regulatoryguidance/Devices/ DirectivesBulletins/index.htm
Medicines and Healthcare products Regulatory Agency (2002) Changes to the reg-
istration of medical devices. http://www.mhra.gov.uk/Publications/Regulatoryguid-
ance/devices/ otherdevicesregulatoryguidance/CON007535
Medicines and Healthcare products Regulatory Agency (2006) Single-use medical
devices: Implications and consequences of reuse. Medicines and Healthcare prod-
ucts Regulatory Agency Device Bulletin DB 2006 (04). London: MHRA. www.mhra.
gov.uk/Publications/Safetyguidance/DeviceBulletins/CON2024995
Medical Devices Agency (2002) DB 2002 (05): Decontamination of endoscopes.
London: MDA. www.mhra.gov.uk/Publications/Safetyguidance/DeviceBulletins/
CON007329
56
Medical Devices Agency (2002) DB 2002 (05): Benchtop steam sterilizers guid-
ance on purchase, operation and maintenance. London: MDA. www.mhra.gov.uk/
Publications/Safetyguidance/DeviceBulletins/CON007326
6.5 British, European and international standards
Note
These were the extant standards at the time of the 2008 survey. Since then, some
may have been superseded or withdrawn.
BS EN ISO 13485: 2003 Medical devices. British Standards Institution 2003.
BS 5925:1991. Code of practice for ventilation principles and designing for natural
ventilation. British Standards Institution, 1991.
BS EN 285:2006+A2:2009. Sterilization. Steam sterilizers. Large sterilizers. British
Standards Institution, 2009.
BS EN 556-1:2001. Sterilization of medical devices. Requirements for medical
devices to be designated STERILE. Requirements for terminally sterilized medical
devices. British Standards Institution, 2001.
BS EN 556-2:2003. Sterilization of medical devices. Requirements for medical de-
vices to be designated STERILE. Requirements for aseptically processed medical
devices. British Standards Institution, 2003.
BS EN 13060:2004. Small steam sterilizers. British Standards Institution, 2004.
BS EN ISO 11607-1:2006. Packaging for terminally sterilized medical devices.
Requirements for materials, sterile barrier systems and packaging systems. British
BS EN ISO 15883-1:2006. Washer-disinfectors. General requirements, terms and
defnitions and tests. British Standards Institution, 2006.
BS EN ISO 15883-2:2006. Washer-disinfectors. Requirements and tests for washer-
disinfectors employing thermal disinfection for surgical instruments, anaesthetic
equipment, bowls, dishes, receivers, utensils, glassware, etc. British Standards Insti-
tution, 2006.
57
BS EN ISO 17665-1:2006. Sterilization of health care products. Moist heat. Re-
quirements for the development, validation and routine control of a sterilization
process for medical devices. British Standards Institution, 2006.
BS EN ISO 14644-1] 1999. Cleanrooms and associated controlled environments.
British Standards Institution, 1999.
BS 6700:2006. Design, installation, testing and maintenance of services supplying
water for domestic use within buildings and their curtilages. Specifcation. British
6.6 Health Service Circulars
Health Service Circular (HSC) 1999/178 Variant Creutzfeldt-Jakob Disease
(vCJD): minimising the risk of transmission. http://www.dh.gov.uk/en/Publication-
sandstatistics/ Lettersandcirculars/Healthservicecirculars/DH_4004969
Health Service Circular (HSC) 1999/179 Controls assurance in infection control:
decontamination of medical devices. http://www.dh.gov.uk/prod_consum_dh/
groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_4077786.pdf
Health Service Circular (HSC) 2000/032: Decontamination of medical devices.
http://www.dh.gov.uk/en/Publicationsandstatistics/Lettersandcirculars/Healthser-
vicecirculars/DH_4002990
6.7 Acts and Regulations
Carriage of Dangerous Goods and Use of Transportable Pressure Equipment
Regulations 2007. SI 2007 No 1573. HMSO, 2007. www.opsi.gov.uk/si/si2007/
uksi_20071573_en_1
Consumer Protection Act 1987. HMSO, 1987. http://www.legislation.gov.uk/uk-
pga/1987/43/contents
Control of Substances Hazardous to Health Regulations (COSHH) 2002. SI 2002
No 2677. HMSO, 2002. www.opsi.gov.uk/si/si2002/20022677.htm
Hazardous Waste (England and Wales) Regulations 2005. SI 2005 No 894. www.
Health Act 2006. HMSO, 2006. http://www.legislation.gov.uk/ukpga/2006/28/
contents
58
Health and Safety at Work etc Act 1974. HMSO, 1974. http://www.hse.gov.uk/
legislation/hswa.htm
Health and Social Care Act 2008. HMSO, 2008. www.opsi.gov.uk/acts/acts2008/
ukpga_20080014_en_1
Medical Devices Regulations 2002. SI 2002 No 618. HMSO, 2002. http://www.
opsi.gov.uk/SI/si2002/20020618.htm
Pressure Systems Safety Regulations 2000. SI 2000 No 128. HMSO, 2000. www.
Waste Electrical and Electronic Equipment Regulations 2006. SI 2006 No 3289.
HMSO, 2006. www.opsi.gov.uk/SI/si2006/20063289.htm
Water Supply (Water Fittings) Regulations 1999.
SI 1999 No 1148. HMSO, 1999.
www.opsi.gov.uk/si/si1999/19991148.htm
6.8 Other publications
Records Management: NHS Code of Practice. 2006. DH. http://www.dh.gov.
uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/
DH_4131747
Coding for Success: 2007. Simple technology for safer patient care. DH. http://
www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAnd-
Guidance/DH_066082.
59
Annex 1: Figure of merit
analysis method
1. Introduction
Figure of merit (FOM) is the system used to score the collected survey data to pro-
vide a basis for further analysis.
FOM uses weighting factors to establish the relative importance of each item under
review. In the NDS 2008/10, each survey question was assigned to the appropriate
Quality System Category. A special sub-group of ESAC-Pr weighted each of these
Quality System Categories on a scale of 1 to 5 (5 being the highest), according to
their relative importance in terms of prion removal and deactivation.
The FOM (%) Score and FOM Rating are two key outputs from the FOM scoring
system:
The FOM (%) Score provides a measure of the merit (or beneft) suggested
by each survey answer. A score of 100% for a specifc answer indicates
that the maximum merit (or beneft) was achieved for that question or
point. However, it should not be possible for a site to score 100% over the
complete survey. This is because of the options available for decontamina-
tion practice at the time of the survey, the way the survey questionnaire is
structured and the fact that two of the negative numerical questions have
a maximum possible score of 50%. A score in the region of 87% should be
considered as the effective maximum possible value for the 2008 survey. In
a repeat survey after the introduction of CFPP 01-01 it should become pos-
sible for excellent service providers to reach fgures above 90%.
The FOM Rating grades each FOM (%) Score using an A to E scale, intend-
ed to assist with the interpretation and comparison of the survey results. As
discussed above, the A rating is not achievable within the present survey but
may be attainable in the repeat exercise.
60
2. Scope of answers scored by FOM
All of the answers collected during the survey were included in the scoring process
except for the following:
2.1 Answers to questions with an FOM weighting of 1 have not been
scored and are excluded from trust reports
DH considers all survey questions assigned a Quality System Category weighting
of 1 to be of minimal relevance in terms of prion removal and deactivation. Scores
are not calculated for these questions, as attempting to do so would produce both
numerator and denominator values of zero in the FOM (%) Score calculation and
therefore an undefned result. However, many of these considerations are of key
concern in the conventional business of cleaning and sterilization. To this end, three
analysis questions related to cleaning practices, staff training and working environ-
ment have been included in this report.
In the current survey, 277 questions have a weighting of 1. A further 10 questions
remain unweighted, because they could not be mapped to a Quality System Cat-
egory in a valid way.
These questions are not included in the trust reports but their exclusion does not
affect the scores achieved.
2.2 Answers to questions not scored for reasons other than FOM weighting
but which are included in trust reports
The following types of question and answer are included in the trust reports but are
not scored:
Text/date questions questions requiring text or date answers;
Object numerical questions questions that are numerical and object-related (for
example, how many sinks do you have?);
Neutral questions questions for which it is not clear whether, for example, a yes
answer should be scored as positive or negative;
61
Questions answered N/A where a researcher has recorded that a question is not
applicable to the site being examined.
3. Calculating the Figure of Merit
3.1 FOM Rating
The FOM Rating grades each FOM (%) Score using an A to E scale and is intended
to assist with the interpretation and comparison of the survey results. The FOM
Rating is derived from this table:
FOM (%) score FOM rating
88 or above A
72 87 B
60 71 C
49 59 D
Below 49 E
3.2 FOM (%) Score
The FOM (%) Score provides a measure of the merit (or beneft) suggested by each
survey answer. A score of 100% indicates that the maximum merit (or beneft) was
achieved.
The FOM (%) Score is calculated using this formula:

3.3 Actual FOM Score
The Actual FOM Score is the actual score achieved by a survey answer expressed as
a decimal fraction after applying the relevant weighting factor. The range of possi-
ble values is between zero and the Maximum Weighted Score.
=
FOM (%) Score

FOM Score
Maximum Weighted Score
100
62
The Actual FOM Score is calculated using this formula:

3.4 Maximum Weighted Score
The Maximum Weighted Score is the maximum score achievable for a survey an-
swer expressed as a decimal fraction after applying the relevant weighting factor. It
therefore determines the maximum value that can be achieved for the Actual FOM
Score.
The Maximum Weighted Score is calculated using this formula:

3.5 Initial Score
The Initial Score is the score recorded for each survey answer before a weighting
factor is applied and before conversion of the score to a decimal fraction.
3.6 Rescaled Score
The Rescaled Score is the Initial Score converted to a decimal fraction scale but be-
fore a weighting factor is applied.
The tables that follow translate each possible binary and numerical survey answer
to an Initial Score.
The Rescaled Score is calculated using this formula:

where x is the Initial Score, x
min
and x
max
respectively the minimum and maximum
possible values for the Initial Score.
Actual FOM Score = Rescaled Score Maximum Weighted Score
Maximum Weighted Score =

Weighting factor 1
4
=

x x
x x
Rescaled Score
min
max min
63
3.7 Scoring the binary questions
Binary questions scored as a positive (yes is the correct/desired answer):
Survey
answer
Initial
score
Min
score
Max
score
Rescaled
score
Yes 1.00 0.00 1.00 1.00
No 0.00 0.00 1.00 0.00
Unknown 0.00 0.00 1.00 0.00
N/A 0.00 0.00 1.00 0.00
<blank> 0.00 0.00 1.00 0.00
Binary questions scored as negative (no is the correct/desired answer):
Survey
answer
Initial
score
Min
score
Max
score
Rescaled
score
Yes 0.00 0.00 1.00 0.00
No 1.00 0.00 1.00 1.00
Unknown 0.00 0.00 1.00 0.00
N/A 0.00 0.00 1.00 0.00
<blank> 0.00 0.00 1.00 0.00
3.8 Scoring numerical questions
Numerical questions with 1 to 5 scale scored as a positive (higher is better):
Survey
answer
Initial
score
Min
score
Max
score
Rescaled
score
1 1.00 1.00 5.00 0.00
2 2.00 1.00 5.00 0.25
3 3.00 1.00 5.00 0.50
4 4.00 1.00 5.00 0.75
5 5.00 1.00 5.00 1.00
<blank> 0.00 1.00 5.00 0.00
64
Numerical questions with a 1 to 5 scale scored as negative (lower is better):
Survey
answer
Initial
score
Min
score
Max
score
Rescaled
score
1 5.00 1.00 5.00 1.00
2 0.00 1.00 5.00 0.00
3 0.00 1.00 5.00 0.00
4 0.00 1.00 5.00 0.00
5 0.00 1.00 5.00 0.00
<blank> 0.00 1.00 5.00 0.00
Note
Where a question uses a 1 to 5 scale, 5 scores as high/always and 1 scores as
low/not at all.
Numerical questions with a 1 to 10 scale scored as positive:
Survey
answer
Initial
score
Min
score
Max
score
Rescaled
score
1 2.00 1.00 11.00 0.10
2 3.00 1.00 11.00 0.20
3 4.00 1.00 11.00 0.30
4 5.00 1.00 11.00 0.40
5 6.00 1.00 11.00 0.50
6 7.00 1.00 11.00 0.60
7 8.00 1.00 11.00 0.70
8 9.00 1.00 11.00 0.80
9 10.00 1.00 11.00 0.90
10 11.00 1.00 11.00 1.00
<blank> 0.00 1.00 11.00 0.00
65
Numerical questions 1 to 10 scale scored as negative:
Survey
answer
Initial
score
Min
score
Max
score
Rescaled
score
1 6.00 1.00 11.00 0.50
2 0.00 1.00 11.00 0.00
3 0.00 1.00 11.00 0.00
4 0.00 1.00 11.00 0.00
5 0.00 1.00 11.00 0.00
6 0.00 1.00 11.00 0.00
7 0.00 1.00 11.00 0.00
8 0.00 1.00 11.00 0.00
9 0.00 1.00 11.00 0.00
10 0.00 1.00 11.00 0.00
<blank> 0.00 1.00 11.00 0.00
Note
The current survey questionnaire contains only four numerical questions where a
scale of 1 to 10 is used. Of these, two score as positive and two as negative.
The wording of the questions using the 1 to 10 scale refers to 10 being 100%
but does not indicate whether a 1 is to be interpreted as zero/not at all, as
would be the case had the 1 to 5 scale been used.
In the table for questions scored as positive, the Initial Score and Max Score have
been incremented by 1 to produce a Rescaled Score which more closely reects
the percentage scale implied by the wording of these questions.
Caveat: Where a researcher recorded a binary Yes answer to this type of numeri-
cal question, the system will amend the answer to a numerical value of 6 (refer to
section 6 of this annex for information on data conversion issues) and calculate the
Rescaled Score as follows:
Original
answer
Amended
answer
Initial
score
Min
score
Max
score
Rescaled
score
Yes 6 6.00 1.00 11.00 0.50
For the questions scored as negative, only the minimum answer value (1) is allo-
cated a non-zero score. However, given the ambiguity in the scale being used for
66
these questions, DH has decided to allocate a Rescaled Score of 0.5 rather than 1.0
where the Initial Score is 1.
A value of 0.5 is consistent with the score that would be achieved had a binary
answer been converted to a numerical.
The relevant survey questions are both in the Vigilance survey category:
439(a)
How frequently, as a % of sets processed, are sets returned for reprocessing found
to have instruments missing? Please indicate the percentage by selecting the appro-
priate number from the drop-down box (10 being 100%)
439(b)
How frequently, as a % of sets processed, are sets returned for reprocessing found
to have instruments which are defective and must be replaced? Please indicate the
percentage by selecting the appropriate number from the drop-down box (10 be-
ing 100%)
4. Quality System Categories
DH has agreed a set of Quality System Categories to facilitate the analysis of the
survey results and has assigned each survey question to an appropriate category.
Weighting factors are scaled from 1 to 5. A weighting of 1 indicates that a survey
question is of minimal relevance in terms of prion removal and deactivation. A
weighting of 5 indicates that a survey question is of the highest relevance in these
terms.
67
4.1 Quality System Categories relevant to prion removal and deactivation
QS_ID
Quality System
Category
Relevant guid-
ance
Relevant EN/
ISO standards
Weighting
factor
No. of
ques-
tions
5
Washing /
disinfection
HTM 2030
HTM 01-01 A
Washer-disin-
fectors
BS EN ISO
15883 1/2/3,
(2006)
5 106
6 Water quality HTM 04-01
Water Supply
BS 6700
(2006)
3 31
7 Inspection
HTM 01-01
Part A
5 68
9
Sterilization /
Steam
HTM 2010
HTM 2031
Steam Steriliz-
ers
BS EN 285
(2006) (Large)
BS 13060
(2004) (Small)
BS EN 556
1 (2001) 2
(2003)
5 144
10 Record keeping
HTM 01-01
Part A
Record Man-
agement Code
of Practice
(2006)
Medical De-
vices, Quality
Management
Systems: BS
EN ISO 13485
(2003)
5 80
11
Instrument
tracking
HTM 01-01
Part A
Coding For
Success (GS1)
5 20
12
Instrument
quality control
ESAC-Pr 2006
MDD Essential
Requirements
Medical De-
vices, Quality
Management
Systems: BS
EN ISO 13485
(2003)
2 22
68
QS_ID
Quality System
Category
Relevant guid-
ance
Relevant EN/
ISO standards
Weighting
factor
No. of
ques-
tions
14
Staffng / train-
ing
IDSc initiative
IHEEM AE(D)
5 32
16
Management
controls
HTM 01-01
Part A,
CQC
MHRA notifed
body.
Medical De-
vices, Quality
Management
Systems: BS
EN ISO 13485
(2003)
5 176
17
Dispatch and
transport
Clean Waste
UN 3291
Trade Bar-
rier Regulations
(2007)
2 44
Number of relevant survey questions 723
Notes
No. of questions refers to the number of questions assigned to each Quality Sys-
tem Category in the NDS 2008/10.
69
4.2 Quality System Categories related to quality of decontamination for general
patient and staff safety purposes
QS_ID Quality System
Category
Relevant guid-
ance
Relevant
EN/ISO
standards
Weighting
factor
No. of
ques-
tions
1
Environmental
control
HBN 13
CFPP 01-01 B
BS EN
ISO
14644
BS 5925
(1991)
1 188
2
Stafng control
HTM 01-01 Part
A
1 11
3
Personal hygiene
HCAI 08 Code
of Practice
1 15
4
Personnel / staff
safety
Health & Safety
at Work Act
1974
1 30
8
Packaging
HTM 01-01
Parts A and B.
BS EN
ISO
11607
(2006)
1 22
13
Microbiological
supervision
HTM 01-01 Part
A,
HCAI 08 Code
of Practice
1 10
15
Disposal
HTM 01-01 Part
A
1 1
- Unmapped ques-
tions
- 10
Number of non-relevant survey questions 287
70
5. Type of question positive, negative and neutral
The Question type determines the scoring method applied to each survey answer.
Question
type
Scoring method No. of
questions
Positive
A yes answer is scored as a positive response and a no
answer is scored as a negative response
896
Negative
A no answer is scored as a positive response and a yes
answer is scored as a negative response
100
Neutral
Answers are indeterminate in terms of their perceived merit
and therefore are not scored
14
Number of survey questions: 1010
6. Data conversion issues
Due to weak data type enforcement in the data capture application, it was possible
for a researcher to record a binary answer against a numerical question and a nu-
merical answer against a binary question. In total, 1,506 answers required conver-
sion (see table in section 6.6, audit keys 6 to 15) out of a total of 50,496.
DH devised the following decision tables to determine the appropriate method of
conversion for each possible case.
6.1 Conversion of binary answers to numerical answers
Where a researcher recorded a binary answer to a non object-related numerical
question, the system amends the answer in accordance with the following decision
table:
Survey
answer
Answer is amended to:
where scale =
1 to 5
where scale =
1 to 10
Yes 3 6
No 1 1
Not applicable 0 0
Unknown 1 1
Not available 1 1
See comment 1 1
71
6.2 Conversion of numerical answers to binary answers
Where a researcher recorded a numerical answer to a binary question, the system
amends the answer in accordance with the following decision table:
Survey
answer
converted to:
1 No
> 1 Yes
6.3 Normalisation of not applicable answers
Where a researcher answered no more than one question in a particular survey cat-
egory the system enters not applicable against all of the unanswered questions in
that survey category. This is done so that non-relevant categories are removed from
the scoring process for each site.
The following table contains a record for the NDS 20082010 of all not applicable
records entered by the system:
Survey category
Category
type
No. of
sites
Total N/A
records
Transport system SSD 1 43
Other sterilizer ENG 19 796
Vacuum bench ENG 25 1,573
Local clinical reprocess-
ing
ENG 20 538
Bench top ENG 23 1,171
Number of normalised records: 28 4,121
72
6.4 Audit table for system-generated answers
Audit
key
Audit subject / answers entered by system
No. of
answers
02
Normalisation of scoring by entering not applicable
against all unanswered questions in blank survey
categories (i.e. those where no more than one an-
swer is recorded)
4,121
03
Normalisation of scoring for additional items of
equipment by entering unknown against unan-
swered questions where the Item no. is greater
than 1
174
04
Normalisation of scoring for additional items of
equipment by entering unknown against unan-
swered questions where the Item no. is 1
7
Number of answers entered by system 4,302
Note
The total number of answers recorded during the current survey was 50,496 (in-
cluding the above total).
73
6.5 Audit table for system-generated amendments to answers
Audit
key
Audit subject / answers amended by system
Refer to
table
No. of
answers
01
Re-mapping of Equipment item no. from 11 to 10 in
Porous Load section to correct error in previous data
capture application
- 322
05
Removal of amended answers where amendment and
original answer are identical
- 8
06
Binary questions numerical answer 1 converted to
binary No
6.2 6
07
Binary Questions numerical answer >1 converted to
binary Yes
6.2 79
08
Numerical questions (1 to 10):
binary answer Not applicable converted to numerical
0
6.1 20
09
Binary answers No, Unknown, Not available or
See comment converted to numerical 1
6.1 5
10
binary answer Yes converted to numerical 6
6.1 1
11
Binary answer Not applicable converted to numerical
0
6.1 743
12
Binary answers No, Unknown, Not available or
See Comment converted to numerical 1
6.1 143
13
6.1 423
14
Object numerical questions:
Binary answer {not Yes} converted to numerical 0
- 82
15
Object numerical questions:
- 4
Number of answers amended by system 1836
74
6.6 Audit table for all recorded survey answers
Audit subject survey answers No. of answers
No. of recorded survey answers 50,496
less irrelevant answers (9,814)
No. of relevant answers 40,682
Relevant answers not scored:
text / date answers (265)
object numerical answers (150)
neutral answers (1,093)
not applicable answers (14,203)
less relevant answers not scored (15,711)
Number of answers scored 24,971
Number of trusts surveyed 26
Number of sites surveyed 30
Note
The above gures include 83 blank answers of which 13 (8 weighted as 1 and
5 that were text answers) were not scored.

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